Position Summary
The Principal Investigator (PI) is responsible for the overall design, conduct, and oversight of clinical research studies conducted at DGD Clinic, P.A. This role ensures the integrity, safety, and compliance of all research activities in accordance with FDA regulations, ICH-GCP guidelines, sponsor requirements, and institutional policies. The PI serves as the lead investigator providing scientific, medical, and ethical oversight for all research protocols, while mentoring the research team to ensure accurate data collection, quality patient care, and successful study execution. Essential Duties and Responsibilities: - Provides overall leadership and direction for assigned clinical trials, ensuring compliance with study protocols, regulatory requirements, and ethical standards.
- Reviews and approves study protocols, informed consent forms, investigator brochures, and other study-related documents.
- Evaluates potential research participants for eligibility and obtains informed consent in accordance with regulatory and institutional guidelines.
- Oversee the safety and well-being of study participants throughout the study lifecycle; reports adverse events, protocol deviations, and safety concerns promptly to sponsors and regulatory bodies.
- Serves as the primary liaison between the research site, sponsors, CROs, IRBs, and regulatory authorities.
- Ensures data integrity and accuracy through consistent oversight, documentation review, and team training.
- Provides ongoing supervision and mentorship to sub-investigators, study coordinators, and research support staff.
- Participates in investigator meetings, site initiation visits, monitoring visits, and audits as required.
- Collaborates with the Research Director and leadership team to identify new study opportunities aligned with clinic capabilities and patient population.
- Upholds the mission, vision, and values of DGD Clinic by promoting a culture of ethical research, clinical excellence, and teamwork.
Qualifications
Education & Experience:
- MD, Or DO in a medical or scientific field required.
- Current unrestricted medical license in the State of Texas (if applicable).
- Minimum 3 years of experience as a Principal Investigator or Sub-Investigator in clinical research.
- Strong working knowledge of FDA regulations, GCP, ICH guidelines, and clinical trial processes.
Skills & Competencies: - Demonstrated leadership and management experience in a research setting.
- Excellent communication and interpersonal skills with multidisciplinary teams.
- Strong attention to detail, organizational, and analytical abilities.
- Ability to manage multiple studies concurrently and meet deadlines.
- Proficiency with EDC systems, CTMS platforms, and Microsoft Office Suite.
- Physical and Work Requirements
- May require prolonged periods of sitting, reviewing documents, and computer work.
- Occasional standing and walking during participant evaluations.
- Must be able to interact professionally with patients, sponsors, and internal staff in a clinical environment.
EMPLOYER'S RIGHTS
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated through the performance evaluation system and part of that evaluation will be based upon your performance of the tasks listed in this job description.
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