Offer summary

Qualifications:

A minimum of 2 years of monitoring experience in oncology trials., Completion of a science-related Bachelor’s degree., Strong knowledge of ICH-GCP guidelines and clinical monitoring processes., Bilingualism in English and Spanish is required..

Key responsabilities:

Performing data verification of source documents.

Conducting site visits including pre-study, initiation, monitoring, and termination.

Ensuring compliance with FDA and ICH-GCP guidelines.

Mentoring junior team members as required.

Job description

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 Argentina.

Responsibilities:

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