Principal Investigator

About the Role

Estimated 1-2 days per week.

We are seeking an experienced and motivated Clinical Research Principal Investigator (PI) with a background in Gastroenterology to support clinical research studies within an established organization.

The Principal Investigator will be responsible for the medical and scientific oversight of assigned clinical trials, ensuring that studies are conducted in accordance with the protocol, Good Clinical Practice (GCP), applicable regulatory requirements, and institutional policies.

This is an opportunity for a physician who is passionate about advancing evidence-based medicine and bringing innovative treatments and healthcare solutions to patients through high-quality clinical research.

Key Responsibilities

• Serve as the Principal Investigator for assigned clinical research studies.
• Provide medical and scientific oversight throughout the study lifecycle, from feasibility and start-up through close-out.
• Assess and recruit appropriate patients and determine eligibility according to study protocols.
• Conduct or oversee study-related medical assessments, physical examinations, and clinical decision-making.
• Ensure participant safety, including evaluation and appropriate management of adverse events and serious adverse events.
• Review and document clinical data and ensure the accuracy, integrity, and timely completion of source documentation and case report forms.
• Ensure compliance with study protocols, GCP, applicable regulatory requirements, and institutional procedures.
• Collaborate with research coordinators, sponsors, CROs, laboratories, pharmacies, and other members of the research team.
• Participate in investigator meetings, site initiation visits, monitoring visits, audits, and regulatory inspections as required.
• Provide clinical guidance and supervision to research staff.
• Review and approve relevant study documentation and medical data.
• Communicate effectively with study sponsors and research partners regarding study progress and participant safety.
• Support identification of suitable clinical trials and contribute to the development of the organization's research portfolio.
• Promote a culture of ethical, patient-centered, and scientifically rigorous research.

Qualifications

• Medical degree (MD, DO, MBBS, or equivalent).
• Board certification or equivalent specialist qualification in Gastroenterology, Internal Medicine, Family Medicine.
• Current medical registration/licensure in the applicable jurisdiction.
• Previous experience as a Principal Investigator or Sub-Investigator in clinical research is strongly preferred.
• Working knowledge of ICH-GCP and applicable clinical research regulations.
• Experience conducting or overseeing industry-sponsored, investigator-initiated, or academic clinical trials.
• Strong understanding of patient safety, informed consent, protocol compliance, and clinical research documentation.
• Excellent clinical judgment, communication, organizational, and leadership skills.
• Ability to work collaboratively with multidisciplinary teams and external research partners.

Preferred Experience

Experience in one or more of the following areas is advantageous:

• Phase I–IV clinical trials
• Chronic disease and primary-care research
• Ulcerative colitis, Crohn's disease or other GI indications experiences prefered.
• Infectious disease or respiratory medicine
• Women's or men's health
• Vaccines or preventative medicine
• Electronic medical records and electronic clinical trial systems
• Sponsor and CRO interactions
• Regulatory submissions and clinical research audits

What We Offer

• Opportunity to lead meaningful clinical research within an established medical practice