Research Safety Reporting Specialist (DOM Infectious Disease)

Research Safety Reporting Specialist

The Transplant Oncology and Infectious Diseases Clinical Research Center (TOID CRC) is looking for a Research Safety Reporting Specialist to be a part of the research team. Our research focuses on solid organ transplantation and, in particular, novel transplantation practices such as organ donation from donors with HIV and hepatitis C. The TOID CRC is responsible for the oversight and management of numerous multi-centered national clinical trials. The Research Safety Reporting Specialist will be responsible for case and event review and reporting and managing internal and external communications to stakeholders. The Clinical Research Compliance Specialist will help ensure adherence to federal regulations related to the registration and reporting of clinical research. This position will develop mechanisms to ensure ethical standards, scientific integrity, and regulatory compliance. This role utilizes survey tools and databases, develops standard operating procedures (SOPs) and training manuals, and maintains frequent communication with research program coordinators, research nurses, and Principal Investigators to register, update, and report results for applicable clinical trials.

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.
• In collaboration 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.
• Prepares 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.
• Other duties as assigned.

Minimum Qualifications

• Bachelor's Degree.
• Three years of related experience with clinical trials or medical
• Additional education may substitute for required experience, and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.