We are seeking a Research Review Specialist who will support research staff to finalize applications to the Johns Hopkins University Institutional Review Board (IRB). They assist the IRB Analyst with the pre-submission review of research protocols and public health practice applications, track the review process after submission, further compliance with progress reports, and develops training workshops, guidance resources, and monitoring systems to facilitate compliance with to institutional regulatory requirements.
They work with the IRB Analyst to ensure investigators and research staff include ethical principles in the design of research projects implemented in the U.S. and abroad. Assists the IRB Analyst in guiding investigators about identifying local IRB's and data collection agencies that meet BSPH ethical requirements.
Specific Duties & Responsibilities
Works closely with the IRB Analyst to assist investigators to prepare research applications for submission to the BSPH IRB in a timely manner.
Provides guidance on compliance and regulatory requirements for the conduct of research.
Critically reviews research plans, recruitment scripts, consent forms, and other study materials, for issues of potential concern, clarity, completeness, etc. prior to submission.
Summarizes and discusses reviews with IRB Analyst and prepares comments for investigators to strengthen applications prior to IRB review.
Uploads research applications to BSPH IRB platform PHIRST 2.0.
Assists to conduct mandatory ethics training/refreshers and presentations for new and existing staff in the Baltimore office and overseas in the country offices.
Provides IRB backstop for IRB Analyst, as needed w/direction.
Assist with management of study regulatory files and archiving of data.
Works with IRB Analyst to develop a dashboard to track research applications, including IRB protocol determinations, local IRB information, dates for approval, expiration, progress reports and closure, and training and certification of research staff.
Develop a system to auto-remind staff of impending IRB activities related to their protocols, and CITI certifications.
Works with IRB Analyst to remain updated in terms of IRB procedures and forms (research plans, consents, data protection, etc.)
Effectively manages multiple tasks in a fast-paced, online environment within expected timelines.
Leadership & Professional Development
Participates in Research & Development division staff meetings and internal learning activities (includes staff meeting, Research in Action, and IDEA labs) and others as relevant.
Develops and conduct IRB-related information and instructional presentations for CCP research and program staff.
Bachelor's Degree required.
Good analytical and writing skills.
Special Knowledge, Skills, & Abilities
Familiarity with IRB procedures.
Basic knowledge of OHRP, and federal regulations related to the protection of human subjects in research.
Ability to learn new software programs.
Proficient in Spanish, Portuguese or French.
Technical Qualifications or Specialized Certifications
Strong working knowledge of software applications such as Microsoft Word, Excel, PowerPoint.
Knowledge of project management databases (Airtable, Microsoft Project etc.) a plus.
Classified Title: Compliance Monitoring Specialist Working Title: Research Review Specialist
Role/Level/Range: ACRP/04/MC Starting Salary Range: $46,560-$64,100-$81,650 Annually (Commensurate with experience) Employee group: Part-time Schedule: Monday - Friday Exempt Status: Exempt Location: Remote Department name: Ctr for Communication Programs CCP Personnel area: School of Public Health
Total Rewards The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: 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.
**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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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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Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.