Psychiatrist

• Act as the primary point of contact for trial-specific medical and safety-related questions
• Provide input for responses to regulatory authorities and IRBs/IECs
• Monitor trial participant safety
• Participate in participant recruitment boost and retention activities
• Present on medical matters at kick-off and investigator meetings
• Train trial teams in the therapeutic area and medical aspects of protocols
• Develop and review trial-specific documents within medical monitoring scope
• Manage ongoing trial risks related to medical monitoring
• Perform ongoing medical review of operational clinical trial databases
• Review protocol deviations, RAE reports, SAE narratives, IND/SUSAR Safety Reports and annual IND reports
• Support Pharmacovigilance, Medical Data Review and Data Management with safety and database reconciliation
• Participate in trial-related committees such as IDMC and adjudication committees
• Review clinical study reports, including safety narratives and TFLs
• Provide medical expertise on an as-needed basis
• Prepare for and participate in trial audits and follow up on audit findings
• Participate in feasibility assessments of potential and ongoing trials in Canada/region
• Participate in bid defense meetings and client interactions
• Act as a medical expert and provide therapeutic expertise to other PSI departments

Explore Medical Monitor, Canada Board-Certified Psychiatrist at PSI CRO AG. Review requirements and application details.