Principal Investigator (MD/DO) - Rheumatology Clinical Trials

Responsibilities

• Conduct standardized disease activity and damage assessments using validated instruments, including: SLICC/ACR Damage Index, BILAG (British Isles Lupus Assessment Group Index), SLEDAI-2K (Systemic Lupus Erythematosus Disease Activity Index), CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index), Physician Global Assessment of Disease Activity (PGA), and Joint count assessment
• 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

• Must be an MD with experience leading at least three sponsor initiated trials as a PI or Sub-I.
• Current, unrestricted medical license.
• Board certification in Rheumatology 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

• This role requires on-site presence at least once per week (or more, depending on study needs), with additional work performed remotely.