Job Description
A client of Insight Global is looking for a strong Nurse practitioner to support the Pfizer Clinical Research Unit. In this role, the Nurse Practitioner/Principal Investigator will provide hands-on medical oversight of clinical trial participants throughout the study lifecycle. A typical day may include reviewing protocols and participant schedules, conducting medical histories and physical examinations, assessing eligibility, overseeing dosing and study-specific procedures, reviewing laboratory results, ECGs and vital signs, evaluating and managing adverse events, and making real-time clinical decisions regarding participant safety. The PI will also communicate regularly with research nurses, clinical research coordinators, sponsor teams, and other investigators; review and sign study documentation; ensure protocol compliance; participate in safety and regulatory activities; and help address unexpected clinical or operational issues that arise during inpatient or outpatient research visits. Pfizer's New Haven PCRU includes both inpatient beds and outpatient facilities, with many Phase 1 studies involving overnight participant stays. Day-to-Day
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Skills and Requirements
Master's or Doctoral degree in Nursing from an accredited program and current, unrestricted Nurse Practitioner licensure in the state of CT.
5-7 years of progressive clinical experience as a Nurse Practitioner, preferably in an acute-care, internal medicine, emergency medicine, research, or other clinically relevant setting.
Demonstrated experience with clinical research and/or clinical trial studies, including familiarity with research protocols, informed consent, participant safety, adverse-event assessment, and study documentation.
Strong knowledge of Good Clinical Practice (GCP), FDA regulations, human-subject protections, and clinical research compliance requirements, with the ability to apply these standards in day-to-day study conduct.
Proven ability to function as a clinical leader and decisionmaker, with excellent communication, organizational, documentation, and multidisciplinary collaboration skills.
