Medical Monitor (US Board-Certified Gastroenterologist)

About the role

PSI Medical Monitors provide medical input to global clinical studies and advise teams and business partners while focusing on patient safety and well-being. This role involves acting as the primary point of contact for trial-specific medical and safety questions and supporting various clinical trial activities.

Responsibilities

• Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions
• Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs)
• Monitors trial participant safety and participates in recruitment and retention activities
• Presents on medical matters at kick-off and investigator meetings
• Trains trial team in the therapeutic area and medical aspects of the protocol
• Develops and reviews trial-specific documents and manages ongoing trial risks
• Performs ongoing medical review of the operational clinical trial database
• Reviews protocol deviations, SAE narratives, and IND/SUSAR Safety Reports
• Supports Pharmacovigilance, Medical Data Review, and Data Management teams
• Reviews clinical study reports and participates in trial audits and bid defense meetings

Required skills

• Gastroenterology
• Clinical research
• Medical monitoring
• Pharmacovigilance
• MS Office
• Communication skills
• Presentation skills
• Analytical skills

Qualifications

• Medical Doctor degree
• US Board Certification in Gastroenterology

About the Company

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a balance between stability and innovation. The company focuses on delivering quality and on-time services across a variety of therapeutic indications.