MD/DO Consultant, Principal Investigator

Responsibilities

• 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.

Requirements

• 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.

Location & Time Commitment

• 3-5 hours per week of remote clinical oversight.
• This position requires being on site in Concord, NC ~2 times per month for key visits.