Experienced Monitor / Clinical Research Associate (CRA)
Core
Conduct on-site monitoring visits for clinical studies (Phases I-III) to ensure data integrity, compliance, and study supply management across various therapeutic indications.
Role type
Clinical Research Associate (CRA)
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, study supply reconciliation, site audit preparation, regulatory submission support, site training
Preferred skills
Oncology indication experience
Technologies
MS Office
Responsibilities
Prepare, conduct, and report site selection, initiation, routine monitoring, and close-out visits; Perform source data verification and follow up on data queries; Ensure proper handling and reconciliation of Investigational Product(s) and clinical study supplies; Review essential study documents and reconcile Investigator Site File (ISF) / Trial Master File (TMF); Conduct site audit preparation visits and resolve audit findings; Conduct project-specific training of site investigators; Support preparation of regulatory and ethics committee submission packages.
Seniority
Mid-level, hands-on IC