Senior Clinical Research Associate-Freelance

Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.

TRIO is looking for a Senior Clinical Research Associate to join our Monitoring Resource team. Reporting to the CRA Line Manager, this position will be a remote full-time freelance position based in Brazil.

Responsibilities:

1. Performing data verification of source documents;
2. Conducting site visits, including pre-study, initiation, monitoring, and termination;
3. Confirming adherence to all FDA, ICH-GCP, and local regulations;
4. Ensuring implementation and compliance with FDA, ICH-GCP guidelines;
5. Participating in budget negotiation and follow-up where applicable;
6. Assisting with data validation and query resolution;
7. Mentoring junior team members as required;
8. Ensuring the completion and collection of regulatory documents.

Qualifications:

1. A minimum of 2 years of monitoring experience in oncology trials;
2. Experience monitoring in early-phase trials will be valued;
3. Completion of a science-related Bachelor’s degree;
4. Excellent knowledge of medical terminology and clinical monitoring process;
5. Strong ICH-GCP knowledge;
6. Experience with clinical trial information systems;
7. Ability to travel up to 60% on average;
8. Bilingualism (English/Portuguese) is required.

Teamwork · Passion · Integrity · Innovation