Cra III / Scra I
Core
Conduct site feasibility, initiation, and monitoring visits to ensure clinical trials adhere to protocols, SOPs, and ICH GCP guidelines.
Role type
Senior Clinical Research Associate (CRA III / SCRA I)
Builds
Clinical trial operations for biotech and pharmaceutical companies
Domain
Clinical Research / Biopharma
Deliverable
client delivery
Required skills
Site feasibility assessment, Study initiation and close-out management, Investigational Product accountability, Source data monitoring, TMF documentation management, Data query resolution, Serious Adverse Event reporting, Audit participation, Mentoring junior staff
Preferred skills
None stated
Technologies
None stated
Responsibilities
Conduct site and investigator feasibility activities; Perform Pre-Study, Study Initiation, Dose Witness, Interim Monitoring, and Close-out visits; Monitor participant source data and review Investigator Site Files; Generate and maintain site visit reports and confirmation letters; Collect and file TMF documentation; Raise and resolve data queries in CRFs; Ensure timely reporting of Serious Adverse Events; Provide guidance and mentoring to less experienced staff during co-monitoring visits
Seniority
Senior, hands-on IC