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Care Access · 1 month ago

Principal Investigator

Arlington Heights

Full-time

Onsite

Senior Level, Lead/Staff

2+ years exp

Care Access is working to make the future of health better for all, focusing on accessible health services and research. The Principal Investigator will oversee clinical trials, ensuring compliance with protocols and participant safety while providing medical support and training to the research team.

Clinical TrialsHealth Care

No H1B

Responsibilities

Provide overall medical oversight and medical review of protocols in conformance with good clinical practice

Review sponsor provided safety reports

Review and maintain accurate case report forms

Ensure that the safety and well-being of all participants in the study at the trial site are protected

Assess subject response to therapy, evaluate and address adverse experiences

Perform physical assessments, examinations and study procedures as required by study protocols

Train Sub-Investigators and study staff members on protocol and protocol specific procedures. Provide medical support to sub-investigators and study staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility

Review the inclusion/exclusion criteria, endpoint criteria, and investigational product use with the internal research team

Complete the necessary Care Access and protocol specific trainings

Comply with ICH GCP (International Conference on Harmonization – Good Clinical Practice) and all applicable regulatory requirements

Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies

Qualification

Clinical Practice (GCP)Medical oversightMDDO licenseClinical trial experienceCommunication skillsCritical thinkingAttention to detailProblem-solving skills