Senior Clinical Research Associate - FSO

We are looking for Senior CRA to join our multisponsor team. This is home based, full time role based in Greece.

Summary of Responsibilities:

- Site management responsibility for clinical studies according to Fortrea’s Standard Operating Procedures, ICH GCP Guidelines, applicable project plans and Sponsor requirements, including verification of study training records.

- Conducts site monitoring responsibilities for clinical trials according to Fortrea’s Standard Operating Procedures (SOPs), ICH guidelines and GCP; including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.

- Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to alongside applicable regulatory requirements.

- Safeguards data integrity by careful source document review, source document verification, query generation, and resolution against established data review guidelines on Fortrea or client data management systems.

- Confirms Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the duration of the trial.

- Guarantees that the study Investigational Product inventory and accountability is accurate and that study materials are stored securely and per protocol requirements.

- Ensures audit readiness at site level.

Qualifications (Minimum Required):

- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.

- Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.

- Fluent in local office language and in English, both written and verbal.

- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience:

- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND

- A minimum of 2 years of Clinical Monitoring experience.

Learn more about our EEO & Accommodations request here .