Research Safety Reporting Specialist (DOM Infectious Disease)

Specific Duties & Responsibilities

• Oversee organizational document management and internal operational systems related to the communication and reporting of events.
• Independently responsible for developing and implementing SOPs for research-related communications with external sites and stakeholders.
• Assist with grant and annual progress report submissions.
• Collaborate with PIs and research team, independently generate patient-facing forms and recruitment materials.
• Develop and maintain research websites including but not limited to MS SharePoint and WordPress.
• Collaborate with TOID CRC Project Managers to prepare, distribute, and manage research memoranda and communications with stakeholders.
• Independently coordinate and communicate with sponsors, federal agencies, external research centers, PIs, and TOID CRC staff.
• Review Adverse Events (AEs) and Serious Adverse Events (SAEs) reported to the TOID CRC for compliance with reporting requirements.
• Prepare AEs and SAEs for review by the medical monitor.
• Submit and track resolution of AEs and SAEs to various reporting agencies as outlined in study-specific Safety Monitoring Plans.
• Initiate and track each data clarification query to resolution as directed by clinical research team and/or standardized SOPs.
• Collaborate with TOID research staff to develop comprehensive safety management plan for each new protocol.
• Assist with the preparation of routine and ad hoc safety reports for review by internal and external safety monitoring boards.
• Demonstrate knowledge of safety concepts, per FDA guidelines.
• Assist in the development of standard operating procedures and regulatory policies related to communication with stakeholders and safety reporting.

Qualifications

• Bachelor’s Degree.
• Three years of related experience with clinical trials or medicine.