Description
We are seeking dynamic and proactive Clinical Research Associates (CRAs) to work full-time with one of our pharmaceutical partners in Finland, preferably based in Southern Finland.
The successful candidate will have site management responsibility for clinical studies according to Fortrea's Standard Operating Procedures, ICH GCP Guidelines, and Sponsor requirements.
Responsibilities:
- Conduct site monitoring responsibilities for clinical trials, including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits
- Prepare and implement project plans related to Clinical Monitoring responsibilities
- Ensure the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to
- Safeguard data integrity by careful source document review, source document verification, query generation, and resolution
- Confirm Site Regulatory documents and applicable eTMF/Sponsor Documents are complete and current
- Guarantee that the study Investigational Product inventory and accountability is accurate
- Ensure adherence to global quality control and CRA performance metrics
- Travel may be required, including air travel, which is an essential function of the job
Requirements:
- University or college degree, or certification in a related allied health profession (e.g., nursing licensure)
- Thorough understanding of ICH GCP Guidelines and local regulatory requirements
- Fluent in local office language (Finnish) and in English, both written and verbal
- A minimum of 2 years of Clinical Monitoring experience for external candidates
Benefits:
- No specific benefits mentioned
Oncology Experience:
- Oncology experience is preferred but not mandatory if you are motivated to learn and develop your experience in oncology studies