Principal Investigator

Job Title: Clinical Principal Investigator Location: US Based - Remote Engagement Type: PRN / Contract (approximately 5–10 hours per week) Overview The Clinical Principal Investigator (PI) provides medical leadership and overall oversight for clinical research studies conducted at various US based sites. This PRN role ensures that all study activities are performed in compliance with ICH-GCP, FDA, and institutional standards, prioritizing participant safety, data integrity, and regulatory compliance. The PI serves as the main point of contact for sponsors, CROs, and study monitors. Key Responsibilities Lead and oversee all clinical trial activities at the site. Evaluate and determine participant eligibility and safety throughout the study. Review and approve study protocols, informed consent forms, and case report documentation. Supervise sub-investigators, research coordinators, and clinical staff to ensure GCP compliance. Oversee investigational product management, including drug accountability and storage. Review and sign off on adverse event and serious adverse event (AE/SAE) reports. Ensure all regulatory documentation and study files are inspection-ready. Maintain ongoing communication with sponsors, IRBs, and study monitors. Analyze study outcomes and contribute to final reports and publications. Qualifications Doctor of Medicine (M.D.) or equivalent from an accredited institution. Active, unrestricted US based medical license. Board certification in Neurology, Pulmonary Medicine, Dermatology, or Internal Medicine (Cardiology, Infectious Disease, Endocrinology, Gastroenterology, and Rheumatology focus) required/preferred. Minimum 5 years of experience as a Principal Investigator or Sub-Investigator in clinical research. Strong understanding of ICH-GCP, FDA regulations, and clinical research ethics. Proven leadership in managing clinical teams and ensuring study compliance. Excellent clinical judgment, organizational, and communication skills. Schedule & Compensation PRN engagement (approx. 5–10 hours per week, variable by study phase). Compensation aligned with Fair Market Value (FMV) for investigator oversight in clinical research. Ref: #568-Clinical