Medical Monitor - Gastroenterologist (Home-Based)

About the role

PSI, a Contract Research Organization with more than 30 years of experience, is hiring a Medical Monitor specializing in gastroenterology. The role is based at home in Argentina and provides medical input to global clinical studies, advises teams and business partners, and keeps patient safety and well-being at the centre of its work.

Key responsibilities

• Act as the main point of contact for all parties on trial-specific medical and safety questions, and provide input 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 on the therapeutic area and protocol
• Develop and review trial documents, manage ongoing medical risks and review the clinical trial database
• Review protocol deviations, SAE narratives and RAE reports, support pharmacovigilance, and update IND/SUSAR reports and annual IND reports
• Take part in IDMC/adjudication committees, trial audits, and feasibility assessments of potential trials
• Support bid defense meetings, act as a medical expert for other PSI departments, and provide medical expertise on an as-needed basis in trials where monitoring is not a contract deliverable

Required profile

• Medical doctor degree
• Practicing gastroenterologist with at least 10 years of experience
• Clinical research experience preferred
• Full working proficiency in English and Spanish

Required skills

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