Job Description

• The Safety Associate is essential for collecting, organizing, and interpreting data accurately to support project-specific safety operations. The Safety Associate focuses on managing and analyzing safety-related data under supervision
• Responsible for ensuring data accuracy and completeness by validating entries and resolving discrepancies during SAE process.
• Work closely with Safety Specialists, Managers, Physicians and Medical Monitors, and cross-functional teams to provide accurate data and reports for analysis.
• Assist in meetings and presentations by preparing data summaries or supporting materials.
• Responsible for Safety-Related Distributions: Manage and distribute safety-related communications, such as safety reports, adverse event notifications, and updates, to relevant stakeholders, including study sites, investigators, and regulatory authorities.
• Responsible for Site Communications: Serve as a liaison for safety-related communications between study sites and the safety team. Ensure timely and accurate communication of safety issues, clarifications, or updates to clinical sites.
• Responsible for Document Control: Maintain and organize safety documentation, ensuring that all safety-related records (e.g., SAE reports, safety letters, regulatory submissions) are stored, tracked, and updated in compliance with project-specific and regulatory requirements.
• Responsible for Safety Box Management: Oversee the maintenance and tracking of safety boxes, ensuring all required documents and safety reports are available, properly archived, and readily accessible.
• Tracking Compliance: Monitor the distribution and receipt of safety-related documents to ensure compliance with project timelines and regulatory guidelines. Track the status of safety reports, document submissions, and follow-ups.
• This role is essential for ensuring that all safety-related documents and communications are managed systematically, ensuring compliance with regulatory and project-specific standards.
• Experienced Safety Associates are responsible for performing MedDRA coding and processing Serious Adverse Events (SAEs) to contribute to the development of comprehensive safety reports.

Job Requirements

• Must have excellent attention to detail, verbal and written communication skills.
• Superior organizational skills and customer service abilities are required.
• Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus.
• General knowledge of the drug and vaccine development process or clinical trials is a plus.
• B.A./B.S. Degree
• This is a hybrid position with 2 days in TRI’s Bethesda, Maryland office, and 3 days working remotely.