Cra III / Scra I
Core
Conduct site feasibility, initiation, and monitoring of clinical trials for biotech and pharmaceutical companies to ensure compliance with protocols and ICH GCP guidelines.
Role type
Senior Clinical Research Associate (CRA III / SCRA I)
Builds
Clinical trial operations and data integrity for emerging biotech therapies
Domain
Biotechnology / Pharmaceutical Clinical Trials
Deliverable
client delivery
Required skills
Site feasibility assessment, Clinical Monitoring Plan development, Pre-Study/Initiation/Close-out visit execution, Source data monitoring, Investigator Site File review, Investigational Product accountability, Data query resolution, TMF documentation management, Serious Adverse Event reporting, Audit participation, Mentoring junior staff
Preferred skills
Experience leading multi-site clinical teams, Protocol review expertise
Technologies
Case Report Forms (CRF), Trial Master File (TMF) systems
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; Ensure Investigational Product accountability; Raise and resolve data queries in CRFs; Collect and file TMF documentation; Participate in sponsor or regulatory audits; Report Serious Adverse Events; Provide guidance and mentoring to less experienced staff during co-monitoring visits.
Seniority
Senior, hands-on IC