Job Description

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 System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Job Tags

Full time, Contract work, Relief, Local area, Remote work, 10 hours per week,

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