Principal Investigator (PI) — Part-Time

Work Location:

El Paso County, Colorado

Summary:

Seeking a part-time Principal Investigator (PI) to provide medical and scientific leadership for clinical research studies across multiple therapeutic areas. This role involves oversight of clinical trials, ensuring participant safety, protocol compliance, and regulatory excellence. The position is ideal for a physician with clinical research experience who is interested in contributing to the growth and success of an independent research site.

Responsibilities:

• Serve as Principal Investigator or Sub-Investigator on assigned clinical research studies, providing oversight and ensuring protocol adherence.
• Participate in pre-study activities (5–10 hrs/week recommended) to become familiar with site operations and staff, with increased on-site presence once a study is awarded.
• Conduct chart reviews, protocol amendments, signatures, and training sessions as required by study protocols and participant population size.
• Review participant eligibility, laboratory results, adverse events, and other clinically significant findings to ensure participant safety.
• Collaborate with research staff and multidisciplinary teams to support study operations, recruitment, and enrollment strategies.
• Maintain compliance with FDA regulations, ICH-GCP guidelines, IRB requirements, and site policies throughout all phases of clinical trials.
• Provide mentorship and medical guidance to research coordinators and staff, fostering a collaborative and patient-centered environment.
• Support business development efforts by participating in feasibility assessments, site qualification visits, and identifying opportunities to expand the clinical trial portfolio.

Qualifications:

• Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO).
• Unrestricted medical license in the State of Colorado.
• Board Certified or Board Eligible in an appropriate specialty.
• Clinical research experience in at least one of the following areas: Endocrinology, Psychiatry, Primary Care / Family Medicine, Dermatology, Pulmonology, or Internal Medicine.
• Previous experience serving as a Principal Investigator on industry-sponsored clinical trials.
• Thorough knowledge of FDA regulations, ICH-GCP guidelines, and Good Clinical Practice.
• Strong leadership, communication, and interpersonal skills.
• Ability to work collaboratively with sponsors, CROs, study participants, and research teams.
• Established relationships with pharmaceutical sponsors, biotechnology companies, or CROs (preferred).
• Demonstrated success in securing or supporting new clinical trial opportunities (preferred).
• Experience with Phase II, III, or IV clinical trials (preferred).
• Experience participating in sponsor feasibility assessments and site selection activities (preferred).
• Clinical research experience across multiple therapeutic areas (preferred).

Published Category:

Clinical Research