Research Safety Reporting Specialist; DOM Infectious Disease

Johns Hopkins, founded in 1876, is America's first research university and home to nine world-class academic divisions working together as one university.

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 nationalclinical trials. The Research Safety Reporting Specialist will be responsible for case and event review and reporting and managinginternal and external communications to stakeholders. The Clinical Research Compliance Specialist will help ensure adherence tofederal regulations related to the registration and reporting of clinical research. This position will develop mechanisms to ensureethical 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, researchnurses, and Principal Investigators to register, update, and report results for applicable clinical trials.

• Oversee organizational document management and internaloperational systems related to the communication and reporting ofevents.
• Independently responsible for developing and implementing SOPsfor research-related communications with external sites and stakeholders.
• Assist with grant and annual progress report submissions.
• In collaboration with PIs and research team, independentlygenerate patient-facing forms and recruitment materials.
• Develop and maintain research websites including but not limited to MS SharePoint and Word Press.
• 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 variousreporting agencies as outlined in study-specific Safety Monitoring Plans.
• Initiate and track each data clarification query to resolutionas directed by clinical research team and/or standardizedSOPs.
• Collaborate with TOID research staff to develop comprehensivesafety management plan for each new protocol.
• Assist with the preparation of routine and ad hoc safetyreports for review by internal and external safety monitoringboards.
• Demonstrate knowledge of safety concepts, per FDAguidelines.
• Assist in the development of standard operating procedures and regulatory policies related to communication with stakeholders andsafety reporting.
• Other duties as assigned.

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

Classified

Title:

Clinical Research Compliance Specialist
Job Posting Title (Working Title):
Research Safety Reporting Specialist (DOM Infectious Disease)
Role/Level/Range: ATP/04/PC
Starting Salary Range: $53,800 - $94,400 Annually ($74,000targeted; Commensurate w/exp.)
Employee group:
Full Time

Schedule:

Monday-Friday 8:30am-5pm
FLSA Status:
Exempt

Location:

School of Medicine Campus
Department name: SOM DOM Infectious Disease
Personnel area:
School of Medicine

The successful candidate(s) for this position will be subject to apre-employment background check.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins…