Description
We are seeking a Senior CRA to join our multisponsor team on a full-time, home-based basis in Greece.
Job Summary As a Senior CRA, you will have site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and applicable project plans and Sponsor requirements.
Responsibilities
- Conduct site monitoring responsibilities for clinical trials, including pre-study, site initiation, process monitoring, routine monitoring, and close-out visits.
- Ensure the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to, alongside applicable regulatory requirements.
- Safeguard data integrity through careful source document review, source document verification, query generation, and resolution against established data review guidelines.
- Confirm site regulatory documents and applicable eTMF/Sponsor Documents are complete and current throughout the trial duration.
- Guarantee accurate Investigational Product inventory and accountability, and secure storage of study materials.
- Ensure audit readiness at the site level.
Qualifications
- University or college degree, or certification in a related allied health profession from an accredited institution.
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
- Fluent in local office language (Greek) and English, both written and verbal.
Experience
- Minimum of 2 years of clinical monitoring experience.