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ABOUT THE ROLE

The Physician Assistant Clinical Researcher is responsible for supervising clinical activities for the clinical trial to which they are assigned. The Physician Assistant Clinical Researcher will promote Good Clinical Practices (GCP) during the conduct of clinical investigations by ensuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of data generated at the site and directing the conduct of the clinical investigation according to regulation/guidance and standard operating procedure (SOP).

WHAT YOU’LL DO HERE

• Supervise the clinical activities for the clinical trial they are assigned.
• Ensure subject safety at all times, this may include but is not limited to: review of clinical laboratory results and/or other test results. Review and/or performance of vital signs, ECGs or other safety tests.
• Record and follow-up on Adverse Events.
• Perform critical trial related tasks and/or make trial related decisions during the course of the trial.
• Ensure subject eligibility is met based on protocol inclusionary/exclusionary criteria and that the subject continues to meet eligibility criteria throughout the course of a clinical trial.
• Ensure requirements related to obtaining informed consent are met.
• Perform physical examinations and medical history intake and review.
• Be on-site for surveillance as required by protocol and remain available on-call for medical events.
• Participate in sponsor visits and regulatory audits.
• Document study related events incompliance with GCP.
• Review study protocols and SOPs.
• Complete and/or review regulatory documents as applicable.
• May act as Principal Investigator on studies at the discretion of the Chief Medical Officer, Medical Director or Senior Principal Investigator.