Description
We are looking for a
Clinical Research Associate (m/f)
Reference: -en
Start: asap
Duration: 12 MM+
Place: in the Basel region
Branch: Herstellung von pharmazeutischen Erzeugnissen
Your tasks:
- Perform routine monitoring visits and close-out visits at the frequency determined for the assigned studies, assuring that the CROs are delivering high quality research
- Report any findings noted at monitoring visits by completing monitoring visit reports to the Clinical Pharmacology study team and the CRO site staff and follow-up letters as per SOPs
- Review and provide input on requested study-related documents and on any CRO-prepared documents such as protocol and protocol amendment, contract, informed consent, defined task of the delegation of authority, case report form, monitoring guidelines, study forms, source documents, clinical study report
- Ensure timely completion of eCRF
- Set-up and reconciliation of the Trial Master File at site
Your qualifications
- University degree in science or health-related discipline and/or degree in Nursing
- Solid experience in clinical research within a CRO or pharmaceutical company with experience in monitoring on-site clinical trials
- Strong knowledge of ICH-GCP guidelines and other applicable regulatory requirements
- Understanding of drug development process
Skills:
- CRA
Keywords: CRA