Experienced Monitor / Clinical Research Associate (CRA)
Core
On-site clinical monitoring for Phase I-III studies across various therapeutic indications, ensuring data integrity, compliance, and site performance.
Role type
Clinical Research Associate (CRA)
Builds
Clinical study data and regulatory documentation
Domain
Clinical Research / Life Sciences
Required skills
Source data verification, Adverse Event reporting, Investigational Product management, TMF/ISF reconciliation, Site audit preparation, Protocol deviation management, Site selection and initiation, Subject recruitment tracking, Regulatory submission support
Preferred skills
Oncology experience
Technologies
MS Office
Responsibilities
Conduct site selection, initiation, routine, and close-out visits; Perform source data verification and follow up on data queries; Ensure proper handling and reconciliation of Investigational Products; Review essential study documents and reconcile TMF/ISF; Conduct site audit preparation visits and resolve findings; Train site investigators; Support regulatory and ethics committee submission packages.
Seniority
Mid-level, hands-on IC