Clinical Safety Assistant

• Manage the distribution of safety reports to reviewing parties, including reception, tracking, distribution/submission, follow‑up on confirmation of receipt, and filing.
• Manage the administrative aspects of Serious Adverse Event (SAE) reporting, including reception and tracking of SAE reports.
• Perform data entry of designated SAE fields into the safety database.
• Provide support to manage investigator site user access to the Safety Distribution System.
• Provide support for Third Party Organization (TPO) oversight to ensure appropriate monitoring and follow‑up of safety reporting activities.
• Set up trial-specific instructions for Medical Affairs documents applicable to Trial Master File (TMF) filing, including folder structure and file naming conventions.
• Maintain timely TMF filing for Medical Affairs documents.
• Maintain the TMF QC schedule, participate in QC activities, and support issue resolution.
• Participate in the creation and revision of Trial Written Instructions (TWIs), as applicable.
• Provide administrative support to the Medical Affairs team in study-related activities (e.g., mailings, filing, team roster maintenance, document tracking, meeting minutes).

• Minimum diploma in a science-related field
• Minimum of two years’ experience as an administrative assistant or coordinator
• Fluent in written and spoken English
• Strong computer skills, including Outlook, Word, and Excel
• Strong attention to detail with excellent organizational skills
• Experience in a medical or clinical trials environment is considered an asset
• Medical knowledge is considered an asset

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