Work Location: Montgomery County, Pennsylvania

Summary:

Seeking an experienced Principal Investigator (MD/DO) to lead and oversee Rheumatology clinical trials on a part-time basis. This role involves both on-site and remote responsibilities, focusing on the management and execution of sponsor-initiated studies in Rheumatology. The position requires strong leadership, clinical expertise, and a commitment to advancing research in a community-based setting.

Responsibilities:

• Lead and supervise all aspects of Rheumatology clinical trials, ensuring compliance with protocols, Good Clinical Practice, and regulatory standards.
• Conduct disease activity and damage assessments using validated instruments such as SLICC/ACR, BILAG, SLEDAI-2K, CLASI, PGA, and joint count assessments.
• Oversee and manage the clinical research team, including sub-investigators and study coordinators, ensuring proper delegation and training.
• Review patient assessments, including physical exams, medical histories, and eligibility screenings, both on-site and remotely.
• Interpret laboratory results, ECGs, and other diagnostic tests, making critical medical decisions regarding participant care and protocol deviations.
• Ensure accurate and timely documentation of study data and findings, contributing to ongoing research protocols and registries.
• Communicate with sponsors, CROs, IRBs, and regulatory authorities, participating in site initiation, monitoring visits, audits, and inspections.
• Maintain investigational product accountability and stay current with advancements in clinical research and Rheumatology through continuous education.

Qualifications:

• MD or DO with experience as Principal Investigator or Sub-Investigator on at least three sponsor-initiated Rheumatology clinical trials.
• Current, unrestricted medical license.
• Board certification in Rheumatology preferred.
• Comprehensive knowledge of ICH-GCP guidelines, FDA regulations, and clinical research ethics.
• Demonstrated leadership and team management abilities.
• Excellent clinical judgment, decision-making, and organizational skills.
• Strong verbal and written communication skills in English.
• Ability to manage multiple complex studies and prioritize tasks effectively.
• Commitment to ethical conduct and patient safety.

Published Category: Clinical Research