About this position
Position Summary
The Principal Investigator (PI) provides medical leadership and regulatory oversight for industry-sponsored clinical trials conducted at the site. The PI retains ultimate responsibility for the conduct of assigned studies in accordance with FDA regulations and ICH-GCP guidelines, while working within a highly supported research model that includes full-time, experienced mid-level Sub-Investigators (NPs/PAs) and dedicated clinical research staff.
This role is well-suited for both experienced PIs and clinicians new to the PI role, offering robust operational support that allows the PI to focus on medical decision-making, subject safety, regulatory compliance, and Sponsor collaboration.
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Key Responsibilities
Clinical & Regulatory Oversight
- Serve as Principal Investigator for industry-sponsored clinical trials within assigned therapeutic areas
- Maintain ultimate regulatory responsibility for study conduct, subject safety, and protocol compliance
- Appropriately delegate study-related activities to qualified Sub-Investigators and research staff while providing ongoing supervision in accordance with FDA regulations and ICH-GCP
- Provide medical oversight for subject eligibility, treatment decisions, and clinical assessments
- Review, assess, and approve adverse events (AEs), serious adverse events (SAEs), safety narratives, and protocol deviations
- Ensure informed consent processes are conducted appropriately and consistently
- Participate in monitoring visits, audits, and regulatory inspections as required
Collaborative Research Model
- Supervise and collaborate with full-time mid-level Sub-Investigators (NPs/PAs) who support protocol-required visits and assessments under the PI’s oversight
- Work closely with Study Coordinators and site leadership to ensure high-quality study execution
- Contribute to a culture of quality, compliance, and patient-centered research
Patient Engagement & Community Collaboration
- Support patient engagement and retention initiatives designed to improve awareness of clinical research opportunities
- Collaborate with local healthcare providers, referral partners, and community organizations to provide education and information about ongoing and upcoming research studies
- Serve as a clinical resource to help expand access to research for the local patient population
Sponsor Engagement & Business Development
- Serve as a medical and scientific representative of the site in interactions with Sponsors and CROs
- Participate in feasibility assessments, protocol review, and protocol design consultation when requested
- Support business development efforts through key client meetings, bid defenses, and therapeutic area discussions
- Contribute clinical insight to support study selection and research program growth
Specialty Focus
Psychiatry
- Mood disorders, anxiety disorders, depression, schizophrenia, and related psychiatric indications
CNS
- Alzheimer’s disease, Parkinson’s disease, neurodegenerative, cognitive, and neurological disorders
Gastroenterology
- NASH/MASH, IBS-C, IBS-D, metabolic liver disease, and functional GI disorders
Qualifications
- MD or DO (required)
- Board-certified or board-eligible in relevant specialty
- Active, unrestricted medical license
- Interest in or prior experience with industry-sponsored clinical research
- Strong understanding of, or willingness to be trained in, FDA regulations and ICH-GCP
- Excellent communication, documentation, and collaborative leadership skills