Clinical Research Associate Closeout H/F - 75

Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will be responsible for monitoring clinical studies and ensuring compliance with regulatory requirements, while supporting investigators and site staff to ensure the safety and integrity of participants.

Main Responsibilities:

- Perform closeout visits in accordance with study protocols and GCP guidelines.
- Ensure timely and accurate collection of study data, including on-site source data verification.
- Assist in the preparation of monitoring reports, ensuring compliance with internal and external standards.
- Provide training to site staff on protocol requirements, data entry, and study procedures.
- Communicate effectively with study teams and site personnel regarding study progress and challenges.
- Identify and resolve issues that may impact the integrity of data or the rights and safety of participants.
- Support the preparation for audits and inspections, maintaining compliance at the site level.