Accurately document findings and contribute to ongoing clinical trials, registries, or research protocols as applicable.
Oversee and manage all aspects of clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements.
Lead and supervise the clinical research team, including sub-investigators, study coordinators, and other site staff.
Delegate study-related duties appropriately to qualified personnel and ensure proper training and oversight.
Conduct remote review of patient assessments, including physical exams, medical histories, and eligibility screenings, to ensure appropriate participant enrollment.
Review and interpret laboratory results, ECGs, and other diagnostic tests.
Make critical medical decisions regarding participant care, adverse events, and protocol deviations.
Ensure accurate, complete, and timely collection and documentation of all study data.
Communicate effectively with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities.
Manage investigational product accountability, storage, and administration according to protocol and with the help of the on-site IP team.
Participate in site initiation visits, monitoring visits, audits, and inspections.
Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas.
Experience as a Principal Investigator on at least 3 sponsor initiated clinical trials.
Medical Doctor (M.D. or equivalent) degree from an accredited institution.
Current, unrestricted medical license.
Board certification in a relevant specialty preferred.
Demonstrated in-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements for clinical research.
Proven leadership and team management skills.
Excellent clinical judgment and decision-making abilities.
Strong verbal and written communication skills in English, with the ability to present complex information clearly and concisely.
Exceptional organizational skills and meticulous attention to detail.
Ability to manage multiple complex studies simultaneously and prioritize tasks effectively.
Commitment to ethical conduct and patient safety.
3-5 hours per week of remote clinical oversight.
This position requires being on site in Lebanon, TN ~2 times per month for key visits.
