Prinicipal Investigator

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.

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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

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