Medical Monitor (Canada Board-Certified Gastroenterologist)
Core
Provide medical input to global clinical studies, advise teams on patient safety, and monitor trial participant safety.
Role type
Medical Monitor (Gastroenterologist)
Builds
Global clinical studies and safety monitoring programs
Domain
Clinical Research / Gastroenterology
Required skills
Medical Doctor degree, Canada Board Certification in Gastroenterology, 10+ years practicing Gastroenterology experience, Clinical Research experience, MS Office proficiency
Preferred skills
Clinical Research experience
Technologies
MS Office
Responsibilities
Act as primary point of contact for trial-specific medical and safety questions; Provide input for responses to regulatory authorities and IRBs/IECs; Monitor trial participant safety; Participate in recruitment boost and retention activities; Present on medical matters at kick-off and investigator meetings; Train trial team in therapeutic area and protocol medical aspects; Develop and review trial-specific documents; Manage ongoing trial risks related to medical monitoring; Perform ongoing medical review of operational clinical trial database; Review protocol deviations; Review RAE reports and write/review SAE narratives; Participate in management of trial-related committees (e.g., IDMC/adjudication committees); Review clinical study reports (CSRs) including safety narratives and tables; Prepare for and participate in trial audits; Participate in feasibility assessment of potential and ongoing trials; Provide therapeutic expertise to other departments.
