Clinical Research Associate II
Core
On-site monitoring of clinical studies across various therapeutic indications to ensure data integrity, compliance, and study quality.
Role type
Clinical Research Associate (IC)
Builds
Clinical trial data and regulatory documentation
Domain
Life Sciences / Clinical Research
Required skills
Source data verification, Adverse Event reporting, Investigational Product management, Site audit preparation, Protocol deviation management, Site selection and initiation, Data query resolution, Regulatory submission support, Site training, TMF reconciliation
Preferred skills
Oncology experience, GI experience, Radio-pharm experience
Technologies
MS Office
Responsibilities
Conduct routine monitoring visits (site selection, initiation, close-out), verify source data, manage Investigational Product accountability, prepare for and participate in site audits, ensure compliance with protocols and regulations, train site investigators, reconcile study documents and supplies.
Seniority
Mid-level, hands-on IC