Principal Investigator / Clinical Research Physician
About the Role:
The Principal Investigator (PI) will oversee all aspects of trial execution, ensuring adherence to ICH/GCP guidelines, FDA regulations, and study protocols. The position focuses on participant safety, data integrity, and ethical compliance. Ideal candidates will be board-certified physicians with experience in clinical research.
In this role, the PI will collaborate with operational teams, clinical staff, and sponsors to ensure successful trial delivery. Responsibilities include providing clinical oversight, patient management, and accurate, timely communication with sponsors and regulatory bodies.
Key Responsibilities:
• Provide clinical leadership for assigned research trials.
• Serve as Principal Investigator, ensuring study compliance with protocols, regulatory standards, and ethical requirements.
• Review and approve trial documents, including protocols and informed consent forms.
• Collaborate with feasibility teams to assess recruitment potential for each study.
• Engage, recruit, and monitor eligible participants to ensure their safety and adherence to trial requirements.
• Conduct medical evaluations and assessments for participant inclusion based on study criteria.
• Partner with site staff, clinical research coordinators, and monitors to ensure accurate and timely data collection.
• Maintain communication with sponsors and CROs to align study goals, timelines, and deliverables.
Qualifications and Skills:
• Board certification in a relevant speciality.
• Valid and unrestricted medical license in the applicable state.
• At least 2 years of experience as a Principal Investigator in clinical trials.
• Comprehensive knowledge of FDA regulations, ICH/GCP guidelines, and clinical research methodologies.
• Proven ability to engage participants and coordinate with research teams to ensure high standards of care.
• Strong organizational and multitasking skills to manage concurrent projects effectively.
• Excellent verbal and written communication skills for interacting with sponsors and documenting trial
progress.
• Experience with patient recruitment and retention strategies.
• Proficiency with electronic data capture systems and clinical trial management platforms.
Education and Experience:
• M.D. or D.O. degree with board certification in a relevant speciality.
• Significant clinical and research expertise.
• Demonstrated track record as a Principal Investigator in clinical studies.
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