Medical Monitor

We are seeking a part‑time remote Medical Monitor who is board‑certified or board‑eligible in Rheumatology to provide medical oversight for an FDA‑regulated clinical trial in dermatomyositis/polymyositis. The Medical Monitor ensures participant safety, protocol compliance, and medical integrity in accordance with FDA regulations, ICH‑GCP, and sponsor standards, and serves as the primary medical point of contact for investigators, study teams, and the sponsor.

This is a 1099 independent contractor position.

• Provide ongoing medical oversight for study participants throughout the trial
• Review participant eligibility prior to Day 0 infusion
• Support pharmacovigilance activities, including review of AEs, SAEs, and SUSARs
• Assess event severity, causality, and expectedness per protocol and Investigator’s Brochure
• Recommend participant management actions, including continuation, modification, interruption, or discontinuation of investigational product
• Provide medical input on protocol design, safety assessments, and risk mitigation strategies
• Review informed consent documents for medical accuracy and clarity
• Respond to investigator inquiries related to eligibility, dosing, protocol interpretation, and safety
• Participate in investigator meetings, site initiation visits, and study team meetings as needed

• Contribute to safety deliverables, including DSURs, IND/CTA safety reports, and line listings
• Participate in DSMB or Safety Review Committee meetings, as applicable
• Review cumulative safety data and identify emerging safety signals
• Support regulatory inspections and audits as needed

• MD or DO from an accredited institution
• Board‑certified or board‑eligible in Rheumatology
• Active, unrestricted U.S. medical license
• Prior experience in clinical trials (Medical Monitor, Safety Physician, Sub‑Investigator, or similar)

• Experience in autoimmune or inflammatory myopathies
• Strong working knowledge of ICH‑GCP and pharmacovigilance principles

• 5–15 hours per month per active study
• Minimal travel may be required (virtual attendance acceptable when permitted)

If you meet the required qualifications and are interested in this role, please apply today.

Solomon Page offers a comprehensive benefit program for hourly employees. We pride ourselves on offering medical, dental, 401(k), direct deposit and commuter benefits to our employees, including freelancers - which sets us apart in the industries we serve.