PRN Principal InvestigatorDSD Recruitment • Plano, TX, US
PRN Principal Investigator
DSD Recruitment • Plano, TX, US
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job_description.job_card.job_descriptionReview and approve study protocols, informed consent forms, and regulatory documents. Ensure all study procedures are performed in accordance with the protocol, GCP guidelines, and IRB requirements. Maintain accurate and complete documentation in the Investigator Site File (ISF). Participate in monitoring visits, audits, site qualification visits (SQVs), and site initiation visits (SIVs) as needed. Work collaboratively with the Site Director, Study Coordinators, and Sub-Investigators. Provide guidance to the research team regarding medical decisions related to protocol conduct. Attend team meetings and training sessions related to ongoing or upcoming studies, as needed. Maintain current credentials, medical license, and GCP certification. Ensure the site is always prepared for sponsor or regulatory authority audits. MD or DO with an active, unrestricted Texas medical license. Board certification or board eligibility in any specialty. Strong interest in clinical research and regulatory compliance. Excellent documentation, communication, and organizational skills. Availability for PRN support (protocol review, eligibility decisions, safety oversight). Previous experience as a Principal Investigator (PI) or Sub-Investigator. Prior clinical research experience (GCP training can be provided). Experience reviewing study protocols or managing patient care in a clinical setting.
Job Description
The Principal Investigator is responsible for the overall conduct of clinical trials at the site, ensuring adherence to FDA, ICH-GCP, and IRB regulations. The PI provides medical oversight, reviews study documents, evaluates participant eligibility, ensures safety, and collaborates with the study team to maintain high-quality research data and patient care.
Key Responsibilities
Clinical Oversight & Patient Safety
- Provide medical and scientific oversight for assigned clinical trials.
- Conduct or oversee physical exams, medical evaluations, and eligibility assessments for study participants.
- Ensure participant safety through timely assessment and reporting of adverse events (AEs) and serious adverse events (SAEs).
Protocol & Compliance Management
Collaboration & Communication
Regulatory Responsibilities
Qualifications
Required :
Preferred :
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Principal Investigator • Plano, TX, US
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