Clinical Trial Principal Investigator

Principal Investigator

Key Responsibilities:

• 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.
• Provide medical oversight and ensure the safety and well-being of study participants throughout the trial.
• Participate in the selection and evaluation of study protocols, ensuring feasibility and alignment with site capabilities.
• 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.

Position Requirements:

• Medical Doctor (M.D. or equivalent) degree from an accredited institution.
• Current, unrestricted medical license in the state of practice.
• Board certification in a relevant specialty preferred.
• Experience (e.g., 5 years) as a Principal Investigator or Sub-Investigator in clinical research trials across various therapeutic areas.
• 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:
This position requires remote oversight of clinical research sites and may require occasional travel for meetings, conferences, or training 1 to 2 times per month.