The Division of Hematology is seeking a Clinical Research Regulatory Specialist that will serve as a central resource for faculty conducting clinical trials at Johns Hopkins University and their multiple locations.
Working closely with the Program Managers and PIs, this position will assist in the submission of NCI CIRB-approved protocols and amendments to the Johns Hopkins Medicine IRB and completing the regulatory requirements for new protocols across multiple programs and diseases within the Division of Hematology.
Specific duties & responsibilities:
Obtain all required documents for new submissions to the IRB
Merge CIRB-approved consents onto the JHM IRB boilerplate.
Work closely with the PI on new studies to ensure timely, accurate submission to the JHM IRB
Track each protocol through the IRB/subcommittee approval process, evaluate for recurrent problems, develop and implement systems to decrease delay in the approval process
Identify start-up requirements (such as FDA Form 1572, conflict of interest disclosures, credentialing requirements, Site Initiation Visits and/or trainings, etc) and work with the appropriate individuals to ensure those items are completed in a timely manner and do not delay study activation
Track all start-up activities to ensure each item is being addressed timely and the study is ready for activation upon JHM IRB approval
Ensure timely implementation of new trials
Produce and maintain an electronic regulatory folder with all required documents, prior to a study starting
Monitor the sponsor's website for protocol amendments, continuing reviews, and notifications
Track and monitor the timelines for amendment submissions and implementation in order to ensure implementation within the sponsor's required timeframe for amendments
Communicate protocol changes to the research team, i.e. PI, co-investigators, research nurses and/or study coordinators
Report timeline delays and process problems to the Program Manager
Additional responsibilities may be incorporated as expertise is acquired
Prepare and submit invoices to sponsors in a timely manner.
Work with Divisional finance staff to ensure that all invoice amounts are collected and reconciled periodically.
Perform all other duties as assigned.
Minimum qualifications (mandatory):
Bachelor's degree, preferably in Life Sciences or related field required. Prefer advanced degree in regulatory, health sciences, biological sciences, or related field.
Minimum of two years of clinical trial regulatory experience at an academic, government, or pharmaceutical industry environment required
Experience working and interacting with patients for at least one year required.
Additional education may substitute for some experience, to the extent permitted by the JHU Equivalency formula.
JHU Equivalency Formula: 18 graduate degree credits may substitute for one year of experience.
Classified Title: Regulatory Specialist Working Title: Regulatory Specialist Role/Level/Range: ACRO40/E/03/CD Starting Salary Range: $16.26-$22.35 Employee group: Full Time Schedule: Mon-Fri; 8:30am-5:00pm Exempt Status: Non-Exempt Location: 04-MD:School of Medicine Campus Department name: 10002811-SOM DOM Hematology Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at email@example.com. For TTY users, call via Maryland Relay or dial 711.
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 Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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