Clinical Research Associate - CRA (Level Depending on Experience)
Core
Conduct clinical trial monitoring at study sites to ensure data quality and regulatory compliance for treatments of chronically and critically ill patients.
Role type
Clinical Research Associate (CRA)
Builds
Clinical trial data and regulatory documentation for pharmaceutical and medical device firms
Domain
Clinical research / Healthcare
Deliverable
physical/clinical work
Required skills
Clinical trial monitoring, site management, regulatory document review, subject enrollment strategy, Investigational Product accountability, remote monitoring, CRF retrieval, source document review, contract negotiation support, ISF/TMF management, corrective and preventive action implementation, therapeutic area expertise
Preferred skills
Lead CRA experience, mentoring/training junior CRAs, process improvement, study start-up activities
Technologies
Clinical trial systems, reporting tools
Responsibilities
Conduct site visits (PSV, SIV, IMV, COV), manage study start-up activities, track essential/regulatory documents, ensure IP accountability, perform remote monitoring, liaise with Clinical Data Management, support contract negotiation, manage ISF and TMF, provide therapeutic area expertise
Seniority
Mid-level to Senior, hands-on IC