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Job description
Johns Hopkins, founded in 1876, is America's first researchuniversity and home to nine world-class academic divisions workingtogether as one university.
The Transplant Oncology and Infectious Diseases ClinicalResearch Center (TOID CRC) is looking for a Research SafetyReporting Specialist to be a part of the research team. Ourresearch focuses on solid organ transplantation and, in particular,novel transplantation practices such as organ donation from donorswith HIV and hepatitis C. The TOID CRC is responsible for theoversight and management of numerous multi-centered nationalclinical trials. The Research Safety Reporting Specialist will beresponsible for case and event review and reporting and managinginternal and external communications to stakeholders. The ClinicalResearch Compliance Specialist will help ensure adherence tofederal regulations related to the registration and reporting ofclinical research. This position will develop mechanisms to ensureethical standards, scientific integrity, and regulatory compliance.This role utilizes survey tools and databases, develops standardoperating procedures (SOPs) and training manuals, and maintainsfrequent communication with research program coordinators, researchnurses, and Principal Investigators to register, update, and reportresults for applicable clinical trials.
Specific Duties & Responsibilities
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 andstakeholders.
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 notlimited to MS SharePoint and WordPress.
Collaborate with TOID CRC Project Managers to prepare,distribute, and manage research memoranda and communications withstakeholders.
Independently coordinate and communicate with sponsors, federalagencies, 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 reportingrequirements.
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 MonitoringPlans.
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 andregulatory policies related to communication with stakeholders andsafety reporting.
Other duties as assigned.
Minimum Qualifications
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 requirededucation 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 ReportingSpecialist (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 whichcampus you will work. Your recruiter will adviseaccordingly.
During the Influenza ("the flu") season, as a condition ofemployment, The Johns Hopkins Institutions require all employeeswho provide ongoing services to patients or work in patient care orclinical care areas to have an annual influenza vaccination orpossess an approved medical or religious exception. Failure to meetthis requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas,laboratories, working with research subjects, or involvingcommunity contact requires documentation of immune status againstRubella (German measles), Rubeola (Measles), Mumps, Varicella(chickenpox), Hepatitis B and documentation of having received theTdap (Tetanus, diphtheria, pertussis) vaccination. This may includedocumentation of having two (2) MMR vaccines; two (2) Varicellavaccines; or antibody status to these diseases from laboratorytesting. Blood tests for immunities to these diseases areordinarily included in the pre-employment physical exam except forthose employees who provide results of blood tests or immunizationdocumentation from their own health care providers. Anyvaccinations required for these diseases will be given at no costin our Occupational Health office.
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Who can apply
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