CRA I
Fortrea
Leiden
1 week ago
CRA I
Site monitoring and site management role for clinical studies at Fortrea in Leiden. Requires basic knowledge of regulatory guidelines and clinical trial processes. Minimum 6 months experience in a related role.
On-site
Full-time
Entry Level
Regulatory Guidelines
ICH GCP
Salary
Not specified
Core Qualifications
Technical (Must-have)
Regulatory GuidelinesICH GCPISO 14155CTMSCRF reviewSAE reportingClinical trial managementMicrosoft OfficeWindows
Soft Skills
communicationteamworkorganizationproblem-solvingplanningattention to detailinterpersonal skillsconfidentiality
Tools (Must-have)
Microsoft OfficeWindowsCTMS
Preferred Qualifications
Technical (Nice-to-have)
Clinical trial management system (CTMS)
Key Responsibilities
- Site monitoring and site management for clinical studies.
- Conduct routine monitoring and closeout of clinical sites.
- Maintain study files and conduct pre-study and initiation visits.
- Ensure protection of study patients and adherence to regulatory requirements.
- Perform source document review and monitor data for missing or implausible data.
- Prepare accurate and timely trip reports.
- Interact with internal work groups to evaluate needs, resources, and timelines.
- Act as contact for clinical trial supplies and vendors.
- Participate in recruitment of investigators and preparation of EC submissions.
- Track and follow up on Serious Adverse Event (SAE) reporting.
Clinical Research AssociateMonitoringClinical TrialsPharmaceuticalBiotechnologyEntry LevelOn-siteNetherlandsLeiden