CRA (Level I)

Thermo Fisher Scientific Inc.; São Paulo; Híbrido; BRL 40.000 - 80.000; Tempo integral

Resumo da oferta

Uma empresa inovadora busca um profissional de monitoramento clínico para coordenar e garantir a conformidade em ensaios clínicos. O candidato ideal terá um bacharelado em ciências da vida ou equivalente, com experiência em monitoramento clínico e habilidades em análise crítica. Esta função envolve visitas a locais para garantir a precisão dos dados e a conformidade com os protocolos, além de colaborar com equipes internas e externas. Se você é apaixonado por pesquisa clínica e deseja impactar a saúde global, esta é a oportunidade perfeita para você.

Qualificações

• Bacharel em Ciências da Vida ou equivalente com experiência mínima em monitoramento clínico.
• Habilidades em análise crítica e resolução de problemas são essenciais.

Responsabilidades

• Coordena o monitoramento clínico e garante conformidade com protocolos e regulamentos.
• Desenvolve relacionamentos colaborativos com sites investigacionais.

Conhecimentos

Análise de Causa Raiz (RCA)

Pensamento Crítico

Resolução de Problemas

Monitoramento de Dados

Comunicação Eficaz

Formação académica

Bacharelado em Ciências da Vida

Certificação de Enfermagem Registrada

Ferramentas

Sistema de Gestão de Ensaios Clínicos

Descrição da oferta de emprego

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from a specific Sponsor and/or monitoring environments (i.e. FSP mainly). Acts as a site processes specialist, ensuring 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. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.

Essential Functions and Other Job Information:

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. Assesses 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 follows 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. May help to identify 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 team as required. Ensures study systems are complete, accurate and updated per agreed study conventions (e.g. Clinical Trial Management System). Facilitates effective communication between investigative sites, the client company and internal project teams through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections. Maintains and 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.

Qualifications:
Education and Experience:
Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic/vocational qualification. Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered. Valid driver's license where applicable.

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.