43 Empregos para Medicina Veterinária Intensiva - Brasil
Estagiário Comercial | Medicina Veterinária
05999-899 São Paulo
Virbac
Publicado há 2 dias atrás
Trabalho visualizado
Descrição Do Trabalho
Com foco na saúde animal, desde o início, a Virbac é uma indústria farmacêutica veterinária de matriz Francesa. Atuante em mais de 100 países ao redor do mundo.
Os produtos abrangem mais de 50 espécies, com uma de produtos e serviços que permite diagnosticar, prevenir e tratar a maioria das patologias. Comprometidos diariamente em melhorar a qualidade de vida dos animais e em moldar juntos o futuro da saúde animal.
Principais Atividades:
- Apoiar os balconistas na venda dos produtos nas lojas, abordando os clientes e explicando as funções dos produtos.
- Atuar buscando informações qualitativas sobre a utilização dos produtos;
- Apoiar verificando as rupturas de estoque dos nossos produtos nas lojas;
- Apoiar na promoção de eventos para divulgação dos produtos, distribuindo materiais de marketing, brindes e amostras
Pré-requisitos:
- Cursando Ensino Superior na área de Medicina Veterinária;
- Disponibilidade para atuar no período de terça a sábado;
Local de trabalho:
Zona Oeste e Zona Sul - SP
Informações adicionais / Benefícios:
- Bolsa Auxilio;
- Seguro de Vida;
- Vale-Refeição ou Vale-Alimentação;
- Vale Transporte;
- Vale Natal e Presente de Aniversário;
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0
CTM / Sr CTM Internal Medicine
Remoto
ThermoFisher Scientific
Publicado há 21 dias atrás
Trabalho visualizado
Descrição Do Trabalho
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Sr Clinical Trial Manager - Make an Impact at the Forefront of Innovation
The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.
**The therapeutic scope includes Cardiovascular & Internal Medicine-** Nephrology, Dermatology, GI, (UC/CD, EOE, EE), Cardiovascular, Liver, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia, Women's Health, Rheumatology, (RA, SLE, Gout), Cell and Gene Therapy, CAR-T in Autoimmune.
**Nephrology:** (CKD, Delayed Graft Function, Antibody-Mediated Rejection, IgA Nephropathy, Lupus Nephritis)
**Dermatology:** Atopic Dermatitis, Psoriasis, Hidradenitis Suppurativa (HS), Prurigo Nodularis, Rosacea, Vitiligo, Alopecia Areata
What You'll Do:
- Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
- Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
- Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
- May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.
- May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
Education & Experience Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities:
- Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
- Good planning and organizational skills to enable effective prioritization of workload
- Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
- Capable of working effectively in a changing environment with complex/ambiguous situations
- Familiarity with the practices, processes, and requirements of clinical monitoring
- Good judgment and decision making skills
- Effective oral and written communication skills, including English language proficiency
- Capable of evaluating workload against project budget and adjusting resources accordingly
- Sound financial acument and knowledge of budgeting, forecasting and fiscal management
- Strong attention to detail
- Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
- Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Frequently drives to site locations and frequently travels both domestic and international.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthroughs.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Sr Clinical Trial Manager - Make an Impact at the Forefront of Innovation
The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs.
**The therapeutic scope includes Cardiovascular & Internal Medicine-** Nephrology, Dermatology, GI, (UC/CD, EOE, EE), Cardiovascular, Liver, Immunology, Rare Disease, Diabetes, Obesity, Dyslipidemia, Women's Health, Rheumatology, (RA, SLE, Gout), Cell and Gene Therapy, CAR-T in Autoimmune.
**Nephrology:** (CKD, Delayed Graft Function, Antibody-Mediated Rejection, IgA Nephropathy, Lupus Nephritis)
**Dermatology:** Atopic Dermatitis, Psoriasis, Hidradenitis Suppurativa (HS), Prurigo Nodularis, Rosacea, Vitiligo, Alopecia Areata
What You'll Do:
- Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
- Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
- Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
- May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.
- May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
Education & Experience Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities:
- Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
- Good planning and organizational skills to enable effective prioritization of workload
- Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
- Capable of working effectively in a changing environment with complex/ambiguous situations
- Familiarity with the practices, processes, and requirements of clinical monitoring
- Good judgment and decision making skills
- Effective oral and written communication skills, including English language proficiency
- Capable of evaluating workload against project budget and adjusting resources accordingly
- Sound financial acument and knowledge of budgeting, forecasting and fiscal management
- Strong attention to detail
- Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
- Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Frequently drives to site locations and frequently travels both domestic and international.
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthroughs.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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1
Médico Veterinário
83260-995 Matinhos
MEDICALPET CLINICA VETERINÁRIA
Publicado há 2 dias atrás
Trabalho visualizado
Descrição Do Trabalho
VAGA PARA MÉDICO(A) VETERINÁRIO(A) PLANTONISTA – PJ
Estamos em busca de Médico(a) Veterinário(a) Plantonista para integrar nossa equipe em clínica veterinária localizada em Paranaguá – PR.
Modelo de contratação: Pessoa Jurídica (PJ)
⏰ Jornada: Plantões de 12 horas, com escala pré-definida
Flexibilidade: Possibilidade de atuar apenas em determinado período do dia, com menor número de plantões, conforme disponibilidade e alinhamento com a equipe.
⸻
Requisitos
Graduação em Medicina Veterinária
Mínimo de 1 ano de experiência em clínica veterinária
Comprometimento, responsabilidade e boa comunicação com tutores
⸻
Remuneração
R$ 200,00 fixo por plantão
10% sobre tudo o que for vendido durante o plantão
Especializações e qualificações são diferencial e contam com melhor remuneração
Média salarial para 15 plantões= R$4500,00 para Clínico geral(Especializações agregam valor à remuneração final)
⸻
Desenvolvimento Profissional
Acreditamos no crescimento contínuo e incentivamos ativamente a profissionalização e capacitação dos nossos colaboradores, valorizando quem busca evolução técnica e científica.
O que oferecemos?
- Estrutura completa com laboratório próprio, internação, centro cirúrgico e diagnóstico por imagem;
- Equipe técnica capacitada e ambiente colaborativo;
- Suporte contínuo e possibilidade de crescimento interno;
- Treinamentos e capacitações periódicas.
Interessados(as) podem entrar em contato via mensagem ou enviar currículo para mais informações.
Maria Cecilia
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2
Descrição Do Trabalho
Descrição da Empresa O Grupo Potiguar é uma organização reconhecida por sua dedicação à excelência e inovação no mercado em que atua. Comprometido com o desenvolvimento das comunidades locais, o grupo busca constantemente proporcionar serviços e produtos de alta qualidade. Valorizamos a colaboração, o crescimento profissional e o bem-estar dos nossos colaboradores.
Descrição do Cargo Procuramos um Laboratorista para atuar em nossa unidade em Macaíba, RN. As principais responsabilidades incluem realizar análises laboratoriais de matérias-primas e produtos, acompanhar o controle de qualidade, preparar relatórios técnicos e garantir o cumprimento das normas de segurança e padrões estabelecidos. Este é um cargo de tempo integral e exige atuação presencial.
Qualificações
Descrição do Cargo Procuramos um Laboratorista para atuar em nossa unidade em Macaíba, RN. As principais responsabilidades incluem realizar análises laboratoriais de matérias-primas e produtos, acompanhar o controle de qualidade, preparar relatórios técnicos e garantir o cumprimento das normas de segurança e padrões estabelecidos. Este é um cargo de tempo integral e exige atuação presencial.
Qualificações
- Habilidades Técnicas: Experiência em análises de laboratório, controle de qualidade e uso de equipamentos laboratoriais.
- Conhecimento de Normas: Familiaridade com normas de segurança e regulamentos aplicáveis à função em ambiente de laboratório.
- Detalhismo e Organização: Capacidade de realizar atividades com precisão, manter registros detalhados e gerenciar prazos.
- Desejável formação técnica ou superior em Química, Engenharia Química ou áreas correlatas, além de prática com ferramentas de informática para geração de relatórios.
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3
Descrição Do Trabalho
Responsabilidades e atribuições:
- Coordenar as operações de Nutrição, integrando Produção, Nutrição Clínica e áreas de apoio, garantindo qualidade assistencial e conformidade com normas e protocolos.
- Gerenciar a produção de alimentos, assegurando segurança alimentar, boas práticas, controle de indicadores, auditorias e melhoria contínua dos processos.
- Monitorar orçamento, custos, contratos e indicadores financeiros, promovendo eficiência operacional e sustentabilidade dos recursos.
- Garantir conformidade com legislações, requisitos regulatórios e certificações, conduzindo ações de qualidade, gestão de riscos e segurança do paciente.
- Liderar e desenvolver as equipes de Nutrição, promovendo dimensionamento adequado, capacitação, avaliação de desempenho e alta performance.
- Desenvolver iniciativas para aprimorar a experiência do paciente, impulsionando inovação, sustentabilidade e projetos de transformação na área de Nutrição.
Requisitos e qualificações:
- Graduação em Nutrição, com registro ativo no Conselho Regional de Nutrição.
- Experiência comprovada de no mínimo 3 anos em cargos de coordenação ou liderança na área de nutrição.
- Conhecimento sólido em planejamento de cardápios, controle de custos e gestão de equipes.
- Pós-graduação em Gestão de Serviços de Alimentação, Gestão de Pessoas ou áreas afins.
- Experiência em empresas de grande porte ou no segmento de alimentação corporativa.
- Conhecimento em sistemas de gestão de nutrição e saúde.
- Habilidades de comunicação, liderança e resolução de problemas.
- Conhecimento em legislação sanitária e boas práticas de manipulação de alimentos.
- Proatividade, capacidade de trabalhar sob pressão e foco em resultados.
Informações adicionais:
Descrição de benefícios
- Plano de saúde (Bradesco Saúde).
- Plano odontológico (Bradesco) para titular e dependentes.
- Seguro de vida pessoal
- Convênio com farmácia Univers (Droga Raia e Drogasil)
- Vale-transporte
- Vale-alimentação
- Refeitório no local para colaboradores da unidade Paraiso e complexo.
- Convênio Academia (TotalPass)
- Cinemark: Ingresso mês do aniversário
- Cuidar Hcor – Atenção Primaria a saúde
Etapas do processo seletivo:
- Triagem
- Teste Técnico
- Entrevista com Atração de Talentos
- Entrevista com a Liderança
- Exame Médico
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4
Descrição Do Trabalho
Veterinary Radiologist - Remote
About SignalPET
SignalPET is a pioneering technology company reshaping veterinary medicine through AI-powered radiograph interpretation. Our mission is to provide fast, accurate, and accessible diagnostic insights to veterinarians around the world.
Role Overview
We are seeking experienced Veterinary Radiologists based in Brazil to join us. In this 100% remote role, you will review AI-assisted radiographic studies, validate findings, and support clinical quality initiatives. This is a unique chance to combine your clinical expertise with innovative technology on a global scale.
Key Responsibilities
- Review and interpret routine small-animal radiographic studies.
- Validate the accuracy of AI-generated reports.
- Provide expert insights and feedback on reported cases.
- Collaborate with veterinarians and fellow radiologists worldwide.
- Participate in quality control and system enhancement projects.
- Stay informed on developments in diagnostic imaging and veterinary AI.
Qualifications
- Médico Veterinário with specialization in Diagnóstico por Imagem or Radiologia Veterinária .
- M.V., MSc or M.V., PhD preferred.
- 5+ years of experience in small animal diagnostic imaging.
- Strong diagnostic and communication skills.
- Proficient in English (written and spoken).
- Self-motivated, reliable, and detail-oriented.
- Comfortable working independently and remotely.
What We Offer
- Fully remote role (Brazil-based).
- Supportive, international team and culture.
- Full training provided—no prior AI experience required.
- A meaningful opportunity to shape the future of veterinary diagnostics.
*** IMPORTANT NOTICE ***
This role has had to be re-advertised due to candidates not responding to LinkedIn messages sent to arrange interviews.
Please ensure that you check your LinkedIn messages daily and respond promptly. Failure to respond may result in your application not being considered further.
We appreciate your cooperation and look forward to hearing from responsive candidates.
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5
Descrição Do Trabalho
O Grupo Petz Cobasi tem como premissa a pluralidade. Por isso, as diferenças são essenciais para a construção de um ecossistema criativo, inovador e descomplicado. Não à toa, somos o maior ecossistema pet do Brasil: pessoas e empresas diversas atuando juntas em prol do bem-estar animal. Se você se identifica e quer construir sua história com um time descomplicado, proativo, focado em resultados e, principalmente, apaixonado por pets, candidate-se. Aqui, queremos que você seja você para, juntos, sermos Petz.
Buscamos um(a) Gerente Fiscal para liderar a área fiscal da companhia, garantindo conformidade tributária, eficiência operacional e suporte estratégico ao negócio.
Responsabilidades
- Gerenciar o planejamento tributário da companhia, acompanhando mudanças na legislação e assegurando o cumprimento das obrigações fiscais e acessórias, com foco em conformidade e eficiência tributária;
- Garantir a apuração, conciliação, compensação e o recolhimento dos tributos diretos e indiretos, incluindo ICMS, PIS, COFINS, ISS, IRRF e CSLL;
- Liderar o fechamento fiscal das operações, incluindo e-commerce, marketplace e importações, assegurando a correta escrituração, a manutenção de regimes especiais e o cumprimento das exigências legais;
- Atuar como parceiro das áreas de Negócios, Comercial, Logística, Operações e Financeiro, oferecendo suporte técnico em questões fiscais e tributárias, bem como na estruturação de novos modelos de negócio;
- Coordenar a parametrização e a evolução dos módulos fiscais do ERP, garantindo aderência às mudanças na legislação e conformidade dos processos sistêmicos;
- Assegurar a regularidade fiscal da companhia, acompanhando certidões negativas, fiscalizações, auditorias e demais demandas dos órgãos competentes;
- Elaborar relatórios gerenciais e análises tributárias para apoiar a diretoria na tomada de decisão e na identificação de oportunidades de otimização fiscal;
- Gerenciar, desenvolver e capacitar a equipe fiscal, promovendo a evolução técnica, a melhoria contínua dos processos e a mitigação de riscos tributários.
Requisitos
- Ensino Superior completo em Ciências Contábeis ou áreas correlatas;
- Necessário pós-graduação ou MBA em Planejamento Tributário, Direito Tributário e/ou Gestão Financeira;
- Vivência em empresas do segmento varejista;
- Sólidos conhecimentos em tributação indireta, com domínio de PIS, COFINS, ICMS, ISS e IPI;
- Experiência com ICMS Substituição Tributária (ICMS-ST) e processos de ressarcimento (CAT);
- Conhecimento em conciliação fiscal e contábil, abrangendo apuração, obrigações acessórias e recolhimento de tributos;
- Vivência em formação de preço de venda, composição de custos e análise dos impactos tributários.
Desejável
- Excel em nível avançado;
- Conhecimento em obrigações acessórias digitais, com atuação em SPED Fiscal, SPED Contribuições e demais obrigações relacionadas.
Modelo de Atuação
- Contratação CLT;
- Modelo híbrido;
- Atuação nas unidades do Pari e Vila Lobos , em São Paulo/SP.
Nossos benefícios
🩺 Assistência Médica
Disponível após o período de experiência, para cuidar da sua saúde com segurança e qualidade.
🦷 Assistência Odontológica
Disponível em até 30 dias após a admissão, garantindo seu bem-estar desde o início.
Participação nos Resultados (PLR)
Bonificação atrelada à performance individual e da companhia.
Clube de Descontos Petz
Descontos e cashbacks exclusivos com mais de 700 parceiros em todo o Brasil. Economia no que realmente importa!
Convênio Farmácia (Vidalink)
Compre medicamentos com desconto direto em folha, sem pesar no bolso.
Day Off de Aniversário
Você merece comemorar! Ganhe uma folga no mês do seu aniversário (disponível após 6 meses de empresa).
Clubz Petz Diamante
30% de desconto em serviços de banho & tosa
5% de CashPetz em compras nas lojas físicas e online
Frete grátis e isenção de taxa de serviço nas compras online (modo econômico/padrão)
30% de CashPetz em consultas, vacinas e exames na rede Seres
Acesso a conteúdos exclusivos
️ GymPass ou TotalPass
Acesso a academias, estúdios e atividades de bem-estar após 30 dias de empresa.
🙋 Indica Petz
Indique amigos para trabalhar com a gente e ganhe recompensas exclusivas. Quem indica, brilha!
Licença PETernidade
Porque pet também é família . Um tempo especial para você cuidar do novo membro da casa.
Movimenta Petz
Nosso programa de mobilidade interna. Aqui você cresce junto com a gente — temos diversos cases de sucesso!
Parceria com o SESC
Descontos, atividades culturais, esportivas e acesso a programas de lazer por todo o Brasil.
Seguro de Vida
Para garantir segurança e tranquilidade a você e sua família.
UniPetz
Nossa plataforma de desenvolvimento online, para você aprender e crescer no seu ritmo.
Vale Refeição ou Vale Alimentação
Benefício concedido de acordo com a política vigente da sua regional.
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6
Assistant CRA
Publicado há 21 dias atrás
Trabalho visualizado
Descrição Do Trabalho
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as an Assistant Clinical Research Associate - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you'll have the opportunity to perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead. As an Assistant Clinical Research Associate, you'll provide support with site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. You may be assigned limited site contact activities during study start-up, site management, recruitment, and close-out phases.
What You'll Do:
- Completes study and site management activities as defined in task matrix, andas applicable and directed for study assigned.
- Completes and documents study-specific training.
- Orients and trains on any study-specific systems.
- Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
- Supports to customize Site ICF with site contact details, as needed.
- Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
- Verifies document collection and RCR submission status; updates site EDL and verifies site information.
- Reviews patient facing materials and review translations, as directed.
- Supports site staff with the vendor related qualification process, where applicable.
- Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
- Provides support to follow-up on site staff training, as applicable.
- Coordinates and supports logistics for IM attendance, as directed.
- Supports maintenance of vendor trackers, as directed.
- Coordinates study/site supply management during pre-activation and subsequentcourse of the study.
- Supports Essential Document collection, review and updating in systems, as applicable.
- Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed.
- Supports ongoing remote review of centralized monitoring tools, as directed.
- Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period.
- Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
- Verifies document collection status in company systems and drives action for missing/incomplete/expired documents and open document findings, as directed.
- May perform other assigned site management tasks, as directed by CRA and as per Task Matrix.
- May perform a specific role profile for FSP opportunities according to Client requests.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Education and Experience Requirements:
- Bachelor's degree in a life science discipline or related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company procedural documents
- Effective oral and written communication skills
- Excellent interpersonal and customer service skills
- Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Proven flexibility and adaptability
- Ability to work in a team or independently, as required
- Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
- Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable
- Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
- Excellent English language and grammar skills
Working Conditions and Environment:
- Work is performed most of the time in an office or home office environment.; occasional travel toclinics/hospitals may be required.
- Exposure to electrical office equipment.
- The Assistant CRA role does not involve regular travel, however, any direct, promotional opportunities in the CRA career track will require frequent travel (60-80%).
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as an Assistant Clinical Research Associate - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you'll have the opportunity to perform remote activities on assigned projects in liaison with the CRA and study Clinical Lead. As an Assistant Clinical Research Associate, you'll provide support with site preparedness, logistical support to the monitoring process, and assist with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines. You may be assigned limited site contact activities during study start-up, site management, recruitment, and close-out phases.
What You'll Do:
- Completes study and site management activities as defined in task matrix, andas applicable and directed for study assigned.
- Completes and documents study-specific training.
- Orients and trains on any study-specific systems.
- Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project.
- Supports to customize Site ICF with site contact details, as needed.
- Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments.
- Verifies document collection and RCR submission status; updates site EDL and verifies site information.
- Reviews patient facing materials and review translations, as directed.
- Supports site staff with the vendor related qualification process, where applicable.
- Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study.
- Provides support to follow-up on site staff training, as applicable.
- Coordinates and supports logistics for IM attendance, as directed.
- Supports maintenance of vendor trackers, as directed.
- Coordinates study/site supply management during pre-activation and subsequentcourse of the study.
- Supports Essential Document collection, review and updating in systems, as applicable.
- Follows up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed.
- Supports ongoing remote review of centralized monitoring tools, as directed.
- Supports Site payments processes by coordinating with various functional departments within organization and site. Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period.
- Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable.
- Verifies document collection status in company systems and drives action for missing/incomplete/expired documents and open document findings, as directed.
- May perform other assigned site management tasks, as directed by CRA and as per Task Matrix.
- May perform a specific role profile for FSP opportunities according to Client requests.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
Education and Experience Requirements:
- Bachelor's degree in a life science discipline or related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Basic medical/therapeutic area knowledge and understanding of medical terminology
- Ability to attain and maintain a working knowledge of ICH GCP, applicable regulations and company procedural documents
- Effective oral and written communication skills
- Excellent interpersonal and customer service skills
- Good organizational and time management skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Proven flexibility and adaptability
- Ability to work in a team or independently, as required
- Well-developed critical thinking skills, including but not limited to critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
- Proficient computer skills with good knowledge of MS Office ability to learn and use appropriate software. Leverage modern technology when applicable
- Ability to extract pertinent information from all study documents, electronic study data systems, CTMS and dashboards
- Excellent English language and grammar skills
Working Conditions and Environment:
- Work is performed most of the time in an office or home office environment.; occasional travel toclinics/hospitals may be required.
- Exposure to electrical office equipment.
- The Assistant CRA role does not involve regular travel, however, any direct, promotional opportunities in the CRA career track will require frequent travel (60-80%).
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Candidatar Agora
7
Descrição Do Trabalho
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Clinical Research Associate (Level II) - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
What You'll Do:
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
- Participates in investigator meetings as necessary. Identifies potential
- investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Responds to company, client and applicable regulatory requirements/audits/inspections.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
- Contributes to other project work and initiatives for process improvement, as required.
Education and Experience Requirements:
- Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
- Valid driver's license where applicable.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving
- Ability to manage Risk Based Monitoring concepts and processes
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Ability to remain flexibile and adaptable in a wide range of scenarios
- Ability to work in a team or independently as required
- Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
Working Conditions and Environment:
- Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
- Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Exposure to fluctuating and/or extreme temperatures on rare occasions
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Clinical Research Associate (Level II) - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
What You'll Do:
- Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
- Participates in investigator meetings as necessary. Identifies potential
- investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Responds to company, client and applicable regulatory requirements/audits/inspections.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
- Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
- Contributes to other project work and initiatives for process improvement, as required.
Education and Experience Requirements:
- Bachelor's degree in a life sciences related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
- Valid driver's license where applicable.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving
- Ability to manage Risk Based Monitoring concepts and processes
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Ability to remain flexibile and adaptable in a wide range of scenarios
- Ability to work in a team or independently as required
- Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
Working Conditions and Environment:
- Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
- Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Exposure to fluctuating and/or extreme temperatures on rare occasions
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Esse trabalho é adequado ou não?
Candidatar Agora
8
Descrição Do Trabalho
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Senior Clinical Research Associate (Level II) - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Senior Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites and client company personnel. You may assist the project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
What You'll Do:
- Monitors investigator sites with a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable
- Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM).
- Participates in investigator meetings as necessary. Identifies potential
- investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Contributes to the project team by mentoring new members, assisting in preparation of project publications/tools including informed consents, CRF guidelines and monitoring plans, and sharing ideas/suggestions with team members. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements & share potential solutions for improvements.
- Performs additional tasks as assigned by CTM or Clinical Manager of CRAs (CM-CRA) (e.g. trip report review, newsletter creation, lead CRA team calls etc).
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Perform QC check of reports generated from CTMS system where required.
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Responds to company, client and applicable regulatory requirements/audits/inspections federal regulatory requirements/audits.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner
Education and Experience Requirements:
- Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years as a clinical research monitor).
- Valid driver's license where applicable.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Effective clinical monitoring skills
- Excellent understanding and demonstrated application of FDA guidelines, ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
- Manages Risk Based Monitoring concepts and processes
- Ability to mentor and train other monitors in a positive and effective manner
- Ability to evaluate medical research data and proficient knowledge of medical terminology
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
- Excellent interpersonal skills
- Strong attention to detail
- Effective organizational and time management skills
- Ability to remain flexible and adaptable in a wide range of scenarios
- Excellent team player with team building skills
- Ability to work independently as required
- Ability to utilize problem-solving techniques applicable to constantly changing environment
- Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
- Effective presentation skills
Working Conditions and Environment:
- Work is performed in an office/laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
- Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals.
- May also include extended overnight stays.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Exposure to fluctuating and/or extreme temperatures on rare occasions.
- Must be able to comply with specific sponsor/client/site requirements, even if not required by
- Thermo Fisher Scientific (e.g., disclosure of vaccination status, or other personal information). On some occasions, this information may be required to be provided directly to sponsor/client/site.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Senior Clinical Research Associate (Level II) - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Senior Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites and client company personnel. You may assist the project manager or clinical team manager on assigned projects and/or may assist in the mentoring and training of junior clinical team members. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
What You'll Do:
- Monitors investigator sites with a risk-based monitoring approach, applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable
- Provides updates on potential trends noted across multiple sites and discusses potential strategies for their management to the Clinical Team Manager (CTM).
- Participates in investigator meetings as necessary. Identifies potential
- investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Ensures trial close out and retrieval of trial materials.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
- Contributes to the project team by mentoring new members, assisting in preparation of project publications/tools including informed consents, CRF guidelines and monitoring plans, and sharing ideas/suggestions with team members. Assists in project specific training for the clinical team where necessary. Identifies areas for potential process improvements & share potential solutions for improvements.
- Performs additional tasks as assigned by CTM or Clinical Manager of CRAs (CM-CRA) (e.g. trip report review, newsletter creation, lead CRA team calls etc).
- Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS). Perform QC check of reports generated from CTMS system where required.
- Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
- Responds to company, client and applicable regulatory requirements/audits/inspections federal regulatory requirements/audits.
- Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner
Education and Experience Requirements:
- Bachelor's degree in a life science related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years as a clinical research monitor).
- Valid driver's license where applicable.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Effective clinical monitoring skills
- Excellent understanding and demonstrated application of FDA guidelines, ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving.
- Manages Risk Based Monitoring concepts and processes
- Ability to mentor and train other monitors in a positive and effective manner
- Ability to evaluate medical research data and proficient knowledge of medical terminology
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
- Excellent interpersonal skills
- Strong attention to detail
- Effective organizational and time management skills
- Ability to remain flexible and adaptable in a wide range of scenarios
- Excellent team player with team building skills
- Ability to work independently as required
- Ability to utilize problem-solving techniques applicable to constantly changing environment
- Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
- Effective presentation skills
Working Conditions and Environment:
- Work is performed in an office/laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
- Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals.
- May also include extended overnight stays.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Exposure to fluctuating and/or extreme temperatures on rare occasions.
- Must be able to comply with specific sponsor/client/site requirements, even if not required by
- Thermo Fisher Scientific (e.g., disclosure of vaccination status, or other personal information). On some occasions, this information may be required to be provided directly to sponsor/client/site.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Esse trabalho é adequado ou não?
Candidatar Agora
9