Clinical Research Associate (m/f)

REFERENZNUMMER:

283842/11

IHRE AUFGABEN:

-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

IHRE QUALIFIKATIONEN:

-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

WEITERE QUALIFIKATIONEN:

CRA