Senior CRA
Core
Conduct and report onsite monitoring visits (SIV, RMV, COV), perform CRF review and source document verification, and manage clinical sites for Phase II/III studies.
Role type
Senior Clinical Research Associate (IC)
Builds
Clinical trial data integrity and site compliance
Domain
Clinical research / Life Sciences
Deliverable
client delivery
Required skills
Independent on-site monitoring, CRF review, source document verification, query resolution, site communication and management, feasibility research, regulatory document preparation, audit and inspection participation
Preferred skills
Phase II/III study experience, therapeutic area expertise
Technologies
MS Office
Responsibilities
Conduct SIV, RMV, and COV onsite monitoring visits; Perform CRF review and source document verification; Resolve monitoring queries; Manage site communication and vendor coordination; Communicate study progress to internal project teams; Participate in feasibility research; Support regulatory submissions; Prepare for and participate in audits and inspections