PRN Principal Investigator

The Principal Investigator is responsible for the overall conduct of clinical trials at the site, ensuring adherence to FDA, ICH-GCP, and IRB regulations. The PI provides medical oversight, reviews study documents, evaluates participant eligibility, ensures safety, and collaborates with the study team to maintain high-quality research data and patient care.

Key Responsibilities

Clinical Oversight & Patient Safety

• Provide medical and scientific oversight for assigned clinical trials.
• Conduct or oversee physical exams, medical evaluations, and eligibility assessments for study participants.
• Ensure participant safety through timely assessment and reporting of adverse events (AEs) and serious adverse events (SAEs).

Protocol & Compliance Management

• Review and approve study protocols, informed consent forms, and regulatory documents.
• Ensure all study procedures are performed in accordance with the protocol, GCP guidelines, and IRB requirements.
• Maintain accurate and complete documentation in the Investigator Site File (ISF).
• Participate in monitoring visits, audits, site qualification visits (SQVs), and site initiation visits (SIVs) as needed.

Collaboration & Communication

• Work collaboratively with the Site Director, Study Coordinators, and Sub-Investigators.
• Provide guidance to the research team regarding medical decisions related to protocol conduct.
• Attend team meetings and training sessions related to ongoing or upcoming studies, as needed.

Regulatory Responsibilities

• Maintain current credentials, medical license, and GCP certification.
• Ensure the site is always prepared for sponsor or regulatory authority audits.

Qualifications

Required:

• MD or DO with an active, unrestricted Texas medical license.
• Board certification or board eligibility in any specialty.
• Strong interest in clinical research and regulatory compliance.
• Excellent documentation, communication, and organizational skills.
• Availability for PRN support (protocol review, eligibility decisions, safety oversight).

Preferred:

• Previous experience as a Principal Investigator (PI) or Sub-Investigator.
• Prior clinical research experience (GCP training can be provided).
• Experience reviewing study protocols or managing patient care in a clinical setting.