Job Title: Clinical Research Principal Investigator

Work Location: Denton County, Texas

Summary:

This position provides medical leadership and oversight for clinical trials, ensuring compliance with regulatory standards and supporting the growth of clinical research activities. The role involves both clinical and business development responsibilities, with a focus on maintaining high standards of patient care and data integrity.

Responsibilities:

• Lead and oversee clinical trials, ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements.
• Conduct medical evaluations, review participant eligibility, and ensure safety monitoring throughout the study lifecycle.
• Obtain informed consent, review and sign off on source documentation and case report forms, and maintain accurate records.
• Collaborate with site coordinators and research staff to ensure protocol compliance and data integrity.
• Participate in sponsor and CRO meetings, respond to safety and efficacy queries, and oversee adverse event reporting.
• Support business development by leveraging professional networks to bring in new clinical studies and opportunities.
• Mentor and guide clinical and research staff, contributing to recruitment strategies and fostering a culture of ethical research.
• Promote continuous quality improvement in site operations and patient care, ensuring a patient-centered approach.

Qualifications:

• Licensed physician (MD or DO) in good standing, with board certification or eligibility in a relevant specialty (e.g., internal medicine, family medicine, psychiatry, endocrinology, GI, liver disease, or related fields).
• At least 1-2 years of clinical practice in a relevant specialty.
• Experience as a Principal Investigator or Sub-Investigator in clinical trials (1-2 years preferred), or significant clinical research experience in a regulated environment.
• Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, FDA and other regulatory requirements, and ethical principles in human subject research.
• Ability to conduct thorough medical assessments, evaluate eligibility criteria, oversee safety monitoring, and make sound clinical judgments for trial participants.
• Effective leadership and team collaboration skills, with the ability to guide coordinators and research staff, manage workflows, and support a patient-centered culture.
• Excellent written and verbal communication skills for interacting with patients, site staff, sponsors, CROs, and regulatory bodies, and for accurate documentation.
• Strong organizational and time-management skills to oversee multiple studies, manage competing priorities, and maintain high-quality documentation and data integrity.
• Comfort with electronic data capture systems, EMRs, and basic digital tools used in clinical research; openness to learning new platforms as needed.
• Commitment to ethical, compassionate, and evidence-based research practices.

Published Category: Clinical Research