Contract Clinical Research Associate
Core
Conduct on-site monitoring for clinical studies in Oncology and Gastroenterology (IBD) to ensure data integrity, compliance, and study quality.
Role type
Senior Clinical Research Associate (Oncology/Gastroenterology)
Builds
Clinical trial data and regulatory documentation for pharmaceutical sponsors
Domain
Clinical Research / Life Sciences
Required skills
Clinical trial monitoring, source data verification, adverse event reporting, protocol deviation management, site selection and initiation, close-out visits, Investigational Product accountability, TMF/ISF reconciliation, audit preparation and participation, site training, regulatory submission support
Preferred skills
Experience in phases I-III trials, MS Office proficiency, multitasking, dynamic team collaboration
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 accurate reporting of Adverse Events and protocol deviations; Manage Investigational Product accountability; Conduct site audit preparation and participate in audits; Train site investigators; Support regulatory and ethics committee submission packages.
