Job Title: PI

Work Location: Dallas County, Texas

Summary:

Seeking a Principal Investigator (PI) to oversee clinical research activities, ensure protocol compliance, and safeguard the rights and welfare of study participants. The PI will be responsible for maintaining regulatory standards, managing study staff, and ensuring the integrity of research data.

Responsibilities:

• Oversee and ensure compliance with clinical research protocols, federal and state regulations, and ethical standards for subject safety and data integrity.
• Complete all required training, including Good Clinical Practice (GCP), IATA, and site-specific SOPs, and maintain up-to-date licensure and credentials.
• Maintain current knowledge of FDA regulations, ICH/GCP guidelines, and study protocols, ensuring all research activities align with these standards.
• Direct and supervise the conduct of clinical investigation protocols, including resource assessment and staff oversight.
• Manage the medical care of study subjects, including conducting informed consent discussions and ensuring patient understanding of procedures, risks, and benefits.
• Ensure accurate documentation of study-related procedures, events, and investigational product handling and storage.
• Attend investigator meetings, develop PI oversight plans, and facilitate ongoing staff training and communication among research teams.
• Support effective communication between patients, healthcare providers, and research staff, and perform additional duties as assigned by management.

Qualifications:

• M.D. or D.O. with an active medical license valid in Texas.
• At least 2 years of experience as a Clinical Research Investigator.
• Board certification or board eligibility in a relevant specialty (e.g., Family Medicine or Internal Medicine).
• Completion of required training and certification in Good Clinical Practice (GCP) and site-specific SOPs.
• Proficient verbal and written communication skills in English; bilingual (English/Spanish) skills preferred.

Published Category: Clinical Research