Principal Investigator (Virtual)
Core
Provide overall medical oversight and review of clinical trial protocols, safety reports, and case report forms to ensure participant safety and regulatory compliance.
Role type
Principal Investigator (Clinical Research)
Builds
Clinical trials for health research and medical breakthroughs
Domain
Healthcare / Clinical Research
Deliverable
client delivery
Required skills
Medical oversight, protocol review, safety reporting, case report form management, adverse event assessment, physical assessments, regulatory compliance (ICH GCP), training sub-investigators
Preferred skills
Prior experience as a Principal Investigator or Sub-Investigator
Technologies
None stated
Responsibilities
Provide medical oversight and review of protocols in conformance with GCP; Review sponsor provided safety reports; Review and maintain accurate case report forms; Ensure safety and well-being of study participants; Assess subject response to therapy and address adverse experiences; Perform physical assessments and study procedures; Train sub-investigators and study staff; Review inclusion/exclusion criteria and investigational product use; Participate in monitoring visits and sponsor meetings
Seniority
Senior, hands-on IC
