Description 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 Requirements 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