Medical Monitor - Canada Board-Certified Gastroenterologist

About the role

PSI, a contract research organization with more than 30 years of experience, is hiring a Medical Monitor who is a Canada Board-Certified Gastroenterologist. The role is home-based in Canada and involves providing medical input to global clinical studies and advising teams and business partners, always with a focus on patient safety and well-being.

Key responsibilities

• Act as the primary point of contact for all parties on trial-specific medical and safety questions
• Provide input for responses to regulatory authorities and IRBs/IECs
• Monitor trial participant safety and take part in recruitment and retention activities
• Present on medical matters at kick-off and investigator meetings and train the trial team
• Develop and review trial documents, manage trial risks and perform ongoing medical review of the clinical trial database
• Review protocol deviations, SAE narratives and RAE reports, support pharmacovigilance and review CSRs
• Take part in IDMC/adjudication committees, trial audits, feasibility assessments and bid defense meetings
• Provide medical expertise on an as-needed basis and to other PSI departments

Required profile

• Medical doctor degree
• Canada Board Certification in Gastroenterology
• At least 10 years of practice as a gastroenterologist
• Clinical research experience preferred

Required skills

• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, teamwork and attention to detail