We are a premier integrated clinical research site network with over 30 locations across the US seeking a Principal Investigator (PI) to lead clinical trials at our Knoxville, TN research site. The PI will provide medical and scientific oversight for Phase I–IV clinical studies across our core therapeutic areas, ensuring the highest standards of patient safety, protocol adherence, regulatory compliance, and data integrity. This role is central to our mission of advancing clinical research through operational excellence, patient-centered care, and high-quality scientific execution.
KEY RESPONSIBILITIES
Clinical Oversight & Patient Safety
- Serve as the medically responsible investigator for assigned clinical trials.
- Perform physical exams, medical evaluations, eligibility assessments, and adverse event reviews.
- Ensure participant’s safety and oversee proper informed consent procedures.
- Provide ongoing medical supervision throughout the study lifecycle.
Protocol Execution & Study Conduct
- Review and fully understand each study protocol, Investigator’s Brochure (IB), and study-specific requirements.
- Ensure trials are conducted in compliance with ICH-GCP, FDA regulations, IRB requirements, and Clinical SOPs.
- Lead and participate in Site Initiation Visits (SIVs), Investigator Meetings, and monitoring visits.
- Oversee study-specific assessments, dosing procedures, safety follow-up, and documentation.
Collaboration & Leadership
- Work closely with Site Directors, Clinical Research Coordinators, Study Nurses, Regulatory staff, and central leadership.
- Communicate proactively with sponsors, CROs, and monitors regarding safety assessments, study conduct, and medical oversight.
- Support recruitment planning and subject engagement strategies to meet or exceed enrollment goals.
- Provide ongoing training and guidance to site staff on protocol-related procedures and study-specific best practices.
Documentation & Compliance
- Ensure accurate, complete, and timely entry and review of source documents, eCRFs, medical notes, and safety reports.
- Document all study-related medical decisions and maintain oversight logs.
- Report SAEs and medically significant events promptly and in accordance with sponsor and regulatory requirements.
Quality & Performance
- Drive high-quality study execution and audit-ready documentation.
- Participate in quality audits and implement CAPA plans when applicable.
- Maintain an up-to-date understanding of clinical trial regulations and therapeutic area developments.
QUALIFICATIONS
Required
- MD or DO with active, unrestricted medical license in the state of Tennessee.
- Board certification (or eligibility) in Internal Medicine, Family Medicine, Endocrinology, Pulmonology, Infectious Disease, Gastroenterology, Neurology, Psychiatry, or another relevant specialty.
- Prior experience as a Sub-Investigator or Principal Investigator preferred; clinical research experience strongly valued.
- Strong clinical judgment, patient-first approach, and commitment to regulatory compliance.
- Excellent communication, leadership, and collaboration skills.
Preferred
- Experience conducting Phase II–III outpatient clinical trials.
- Familiarity with electronic systems such as CTMS, eSource, eCRF platforms.
- Prior work with high-enrolling therapeutic areas (Vaccines, Endocrinology/Diabetes, Pulmonology, GI, etc.).
Pay: $250,000.00 - $325,000.00 per year
Benefits:
- Health insurance
- Paid time off
- Relocation assistance
- Retirement plan
Education:
Experience:
- Research Investigator: 2 years (Preferred)
License/Certification:
- Medical License (Required)
Work Location: In person
