Cra I
Core
Conduct site feasibility, initiation, and monitoring visits for clinical trials to ensure compliance with protocols and GCP guidelines.
Role type
Junior Clinical Research Associate (CRA I)
Builds
Clinical trial monitoring activities for biotech and pharmaceutical clients
Domain
Clinical Research / Biotechnology / Pharmaceuticals
Required skills
Site feasibility assessment, Pre-Study/Initiation/Close-out visit execution, Source data monitoring, Investigator Site File review, Investigational Product accountability, Data query resolution, TMF documentation collection, Serious Adverse Event reporting, Audit participation, Interstate travel
Preferred skills
ICH GCP training, Privacy Legislation awareness
Technologies
Case Report Forms (CRF), Investigator Site Files (ISF), Trial Master File (TMF)
Responsibilities
Conduct site and investigator feasibility activities; Perform Pre-Study, Study Initiation, Dose Witness, Interim Monitoring, and Close-out visits; Generate and maintain site visit reports and confirmation letters; Monitor participant source data and review Investigator Site Files; Raise and resolve data queries in CRFs; Collect and file TMF documentation; Report Serious Adverse Events; Participate in sponsor or regulatory audits.
Seniority
Junior, early career (approx. 12 months experience)