Clinical Research Associate II
Core
Conduct on-site monitoring visits for clinical studies (Phases I-III) to ensure data integrity, compliance, and timely subject recruitment across various therapeutic areas.
Role type
Clinical Research Associate II (Oncology mandatory)
Builds
Clinical trial data and regulatory documentation for sponsors
Domain
Life Sciences / Clinical Research / Oncology (via careerplan.io/jobs/744000130797329-clinical-research-associate-ii-at-psi-cro)
Deliverable
client delivery
Required skills
Source data verification, adverse event reporting, protocol deviation management, Investigational Product accountability, site audit preparation, regulatory submission support, study timeline management
Preferred skills
Oncology experience, GI experience, radio-pharm experience
Technologies
MS Office
Responsibilities
Conduct site selection, initiation, routine, and close-out visits; verify source data and follow up on data queries; manage Investigational Product handling and reconciliation; prepare and reconcile Investigator Site Files and Trial Master Files; participate in site audits; train site investigators; support regulatory and ethics committee submissions.
Seniority
Mid-level, independent execution