CRA - all levels e Lead CRA

We count on you to:

CRA - all levels

• General On-Site Monitoring Responsibilities, including routine monitoring visits and close-out of clinical sites;
• Conduct pre-study visits such as SQV – Site Qualification Visit and SIV – Site Initiation Visits;
• Ensure the integrity of the data submitted on Case Report Forms (CRFs) by carefully reviewing source documents;
• Perform CRF review, including generating and resolving queries, to ensure data quality;
• Maintain study files, ensuring audit readiness at the site level;
• Prepare and provide FUP (Follow-Up) letters and reports within the established deadlines for respective monitoring visits;
• Track and follow up on Serious Adverse Event (SAE) reporting, including producing reports, narratives, and following up on SAEs;
• Track and follow up on Deviation Reports according to the study's plan;
• Act as the focal point of communication between the site team, project manager, and vendors to resolve any arising issues. Liaise with vendors and perform other duties as assigned;
• Ensure that the conduct of clinical trial activities complies with current ethical regulations, Good Clinical Practices, and protocol guidelines;
• Maintain accounting and control of investigational products and other trial materials/supplies;
• Travel, including air travel, will be required and is an essential function of the job. Prepare accurate and timely trip reports and expense reimbursements.

Lead CRA:

• Train, develop and assist Monitoring Team (CRA all levels) and Clinical Research Analysts.
• Identify and evaluate issues in the management of activities of research site, through monitor follow-up and propose resolutions and action plans for the team.
• Support the review of project-related plans, such as monitoring, deviation, risk plans and study specific documents.
• Perform revision of monitoring reports such as site qualification reports (SQV), initiation (SIV), regular monitoring (MoV) and close-out (CoV) reports, ensuring their quality and follow-up on outstanding items and issues.
• Perform sampling review of the eTMF to ensure its quality.
• Develop and support CRAs and analysts, seek process and tool optimization to form high-performance teams.
• Act as the main communication liaison between CRAs, Clinical Project Managers and Clinical Operations Managers.
• Ensure that clinical monitoring activities of the assigned team are conducted to sponsor satisfaction, ensuring quality results in a timely manner, within budget, and in accordance with standard operating procedures (SOPs), local regulations, good clinical practices (GCP), and study-specific requirements.
• Supervise the performance of monitors and analysts, as well as develop performance evaluation metrics and necessary training.
• May be required to provide on-site supervision for CRAs and/or conduct monitoring or co-monitoring (as needed).
• Oversee and maintain study-specific and corporate trackers.
• Supervise CRAs workload and propose adjustments and reallocations of human resources.

What we are looking for:

CRA - all levels

• Complete higher education in Pharmacy, Biomedicine, or Nursing;
• Good Practices in Clinical Research, Initiation Visit, Routine, Close Out, and center qualification;
• Intermediate English;
• Minimum of 2 years' experience in clinical research as a clinical research analyst, or previous experience as a research center coordinator.
• Availability for travel.

Lead CRA:

• Complete higher education: Pharmacy, Biomedicine, Nursing etc.
• At least 6 - 7 years of experience working as CRA - Clinical Research Associate.
• Behavioral skills: ethics, integrity, effective communication, teamwork, flexibility, leadership and well organization.
• Advanced English.
• Desirable Spanish.
• Availability for travel.

Work Unit:

• Administrative Headquarters: Paulínia/SP - Home Based.

What benefits we offer you:

• Transportation allowance.
• Parking (subject to availability).
• Heath Insurance with no monthly cost to employee, with co-participation for exams and medical consultations.
• Dental plan with monthly co-participation.
• Life Insurance.
• Food/Meal allowance.
• Pharmacy benefit.
• Vaccination program.
• Confidencial (Apenas para Cadastrados) Partnership Club (Education Institutions, Language Learning, Leisure and Cultural Activities).
• Hybrid Work Model (to be aligned with leadership).
• SESC Partnsership;
• Physical health program - TotalPass.
• Heath Professional - Day off.
• Nursery assistance (as per internal policy).

Somos uma empresa com cultura jovem, inovadora e apaixonada pela missão de melhorar a vida de cada vez mais pessoas.

Presente nas cidades de Campinas, Paulínia e São Paulo, atuamos apoiando à indústria farmacêutica no desenvolvimento e registro de novos medicamentos e oferecendo serviços de diagnósticos para laboratórios em todo o Brasil.

NOSSO JEITO DE TRABALHAR

Com 20 anos de experiência nas áreas de saúde e tecnologia e mais de 800 colaboradores, nossa cultura é orientada por valores fundamentais: a integridade; o protagonismo; e a inovação e excelência.

Acreditamos no impacto positivo do nosso trabalho através dos nossos times e dos nossos serviços, por isso, incentivamos o desenvolvimento profissional dos nossos colaboradores e contamos com Programas de Estágio, Aprendiz e o Aceleração de Carreiras.

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Vamos juntos melhorar a vida de cada vez mais pessoas? 🚀💜