Clinical Research Associate

As a member of the Clinical Operations team, and in line with the Pharmaceutical Unit Development objectives, the incumbent participates in the preparation and follow-up of clinical studies. You will be working on innovative national and/or international projects in a variety of therapeutic areas. The position is based on the Libourne campus, but national and international travel is to be expected.

In this capacity, your missions are:
Contribute to the drafting and management of study documents.
Select investigator sites, set up contracts and ensure payment of invoices.
Manage investigator center logistics (products, biological samples, materials, etc.).
Monitor clinical trials in compliance with pharmaceutical regulations and in particular Good Clinical Practices: conduct monitoring visits (initiation, interim and closure) to investigator centers, draft regular monitoring reports and maintain management charts throughout the study.
Guaranteeing the quality and integrity of the data collected: monitoring and managing requests for corrections.
Work closely with the data managers to provide an accurate and complete database.
Participate in quality audits carried out during the study.

**Your profile**:
Higher scientific education (Master 2) in life sciences, biology, biotechnology,...

**Technical skills**:

- Good knowledge of international regulations, ICH (VICH GL9 would be a plus)
- Good command of written and spoken English
- 3 to 5 years' experience as a CRA within a CRO and/or a laboratory desirable
- Desired knowledge of the RBQM approach and experience using CTMS/eTMF, EDC, ePRO

**Softskills**:

- Organized and rigorous
- Flexibility and diplomacy
- Good communication and team spirit