Medical Monitor (US Board-Certified Gastroenterologist)

PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.

Home-Based in United States

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) on trial-specific medical and safety-related questions
• Monitors trial participant safety
• Participates in trial participant recruitment boost 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 within the scope of medical monitoring
• Manages ongoing trial risks related to medical monitoring
• Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial
• Reviews protocol deviations
• Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues
• Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request)
• Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s)
• Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases
• Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs)
• Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable
• Prepares for and participates in trial audits, follows up on audit findings
• Participates in feasibility assessment of potential and ongoing trials in the country/region
• Participates in bid defense meetings and other interactions with clients
• Acts as a medical expert and provides therapeutic expertise to other PSI departments

• Medical Doctor degree required
• US Board Certification in Gastroenterology required
• Experience as a practicing Gastroenterology (minimum of 10 years)
• Clinical Research experience preferred
• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, team and detail-oriented

For this position, PSI is not hiring individuals who require work visa sponsorship for employment now or in the future.