Clinical Research Associate - CRA (Level Depending on Experience)
Core
Conduct on-site and remote monitoring of clinical trials for chronically and critically ill patient populations, ensuring data quality and regulatory compliance across the study lifecycle.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data integrity and regulatory compliance for pharmaceutical and biotechnology clients
Domain
Clinical Research / Healthcare
Deliverable
physical/clinical work
Required skills
Clinical trial monitoring, site management, regulatory document review, Investigational Product (IP) accountability, subject enrollment strategy, remote monitoring, corrective and preventive action (CAPA), therapeutic area expertise
Preferred skills
Lead CRA experience, mentoring/training junior CRAs, process improvement, contract negotiation support
Technologies
Clinical trial management systems, source document review tools
Responsibilities
Conduct site visits (PSV, SIV, IMV, COV), manage study start-up activities, track essential/regulatory documents, ensure IP storage and dispensation, liaise with Clinical Data Management, manage Investigator Site Files (ISF) and Trial Master Files (TMF), provide therapeutic area expertise to team members
Seniority
Mid-level to Senior (3+ years experience required)