Prinicipal Investigator

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.

________________________________________

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