Classified Title: [[IRB Analyst]] Working Title: [[IRB Analyst]] Role/Level/Range: ATP/04/PC Starting Salary Range: [[$50,200 - $69,089]] Employee group: Full Time Schedule: [[Monday - Friday, 8:30a - 5:00p / 37.5 hrs per wk]] Exempt Status: Exempt Location: 05-MD:School of Public Health Department name: 10001038-JHSPH Institutional Review Board Office Personnel area: School of Public Health
The IRB Analyst reports to the Executive Director of the JHSPH IRB. Primarily responsible for mastering, and keeping up with changes associated with, the DHHS regulations on human subjects research (the Common Rule and the Revised Common Rule), the FDA regulations on investigational drugs and devices, HIPAA, and Good Clinical Practices (GCP)
Specific Duties & Responsibilities
Conducting administrative and regulatory review of assigned IRB human subjects research submissions: New Applications, Amendments, Continuing Reviews, etc.
Ensuring the submission meets the U.S. government, and state and local regulatory requirements for human subject research
Ensuring the submission complies with JHU institutional policy
Determining the level of review (administrative, exempt, single reviewer, convened) for IRB submissions
Assisting with planning, managing, and coordinating of IRB meetings
Generating and distributing agenda materials and review forms for IRB members
Communicating with investigators and IRB member-primary reviewers to prepare submissions for review
Ushering assigned IRB submissions through the review process, ensuring recordation of the outcome of the review, and working with administrative staff on the IRB correspondence with researchers communicating the outcomes
Coordinating review between collaborating institutions locally and internationally
Assuring compliance and with reciprocity agreements (if applicable) and the associated institutions
Interacting, advising and consulting with IRB members, interdivisional regulatory offices, Federal, State and local agencies and the community on current and changing ethical, administrative, regulatory and community issues regarding the protection of research subjects
Advising and assisting investigators, students, and staff about JHSPH IRB Office and IRB requirements in compliance with FDA and OHRP human subjects' regulations and policies
Utilize custom software (PHIRST, IRB Database) in the day to day review, management, and recording processing of study submissions
Resolving, negotiating and documenting ethical and regulatory concerns with investigators and IRB members in accordance with JHSPH institutional policies, the Human Research Protection Program policies & procedures and Federal, State and local policies involving human subjects research
Working with IRB staff colleagues on maintaining and updating the JHSPH IRB Office SOPs
Participating actively in IRB Office staff meetings
Completing ethical training programs offered by PRIM&R, the Berman Institute, and other Hopkins resources
Managing the IRB Office's HIPAA portfolio, and maintaining the tracking information required by the JHM Privacy Office
Bachelor's degree required.
Three years of related experience writing/editing medical or pharmaceutical documents or consent forms is required.
Graduate level training may substitute for up to two years of experience, to the extent permitted by the JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job. *
The successful candidate(s) for this position will be subject to a pre-employment background check.
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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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