Clinical Research Associate II
Core
Conduct on-site monitoring visits for clinical studies across various therapeutic indications, ensuring data integrity, compliance, and study supply management.
Role type
Clinical Research Associate (monitoring)
Builds
Clinical trial data and regulatory documentation
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Source data verification, adverse event reporting, protocol deviation management, site selection and initiation, close-out visits, Investigational Product reconciliation, TMF/ISF review, site audit preparation, regulatory submission support, site training
Preferred skills
Oncology, GI, radio-pharm experience
Technologies
MS Office
Responsibilities
Prepare, conduct, and report site selection, initiation, routine monitoring, and close-out visits; ensure subject recruitment targets and project timelines are met; verify source data and follow up on data queries; manage study risks; ensure proper handling and accountability of Investigational Products; review essential study documents and reconcile ISF/TMF; conduct site audit preparation and participate in audits; facilitate document and supply flow between project team, site, and central labs/warehouses; train site investigators; support regulatory and ethics committee submission packages.
Seniority
Mid-level, hands-on IC