The Office of Human Subjects Research is seeking an IRB Reliance Analyst who is part of a team that processes human subjects research protocols overseen by the Johns Hopkins Medicine IRB. This fully remote position is responsible for providing administrative support and coordination for the reliance process and relationships between the JHM Human Research Protection Program (HRPP) and outside/external IRBs, including institutional and commercial IRBs. Within the scope of the reliance relationships utilizing the single IRB (sIRB) model, JHM participates as both a relying institution and reviewing IRB. This position will provide technical and administrative support for reviews conducted under the reliance process.

This position has been designated as a 100% remote position. On-site attendance may be required for select meetings or events. Advanced notice will be provided for these circumstances.

Specific Duties & Responsibilities

• Demonstrates knowledge-based understanding of the complete IRB review process.
• Works with minimum supervision to provide administrative support and advice regarding human subjects research applications submitted to the IRB, with a specific focus on submissions subject to a reliance agreement.
  
• Serves as primary point of contact for phone and in-person consultation requests from JHM investigators inquiring about the reliance agreement process.
  
• Triages inquiries submitted through the IRB Reliance email inbox and the reliance request tool.
  
• Conducts administrative review of designated human subjects research application submissions including verification of training requirements related to sIRB review.
  
• Determines level of review appropriate for research submissions.
  
• Advises & assists investigators and their staff [both internal and external to the institution] regarding the submission of applications in accordance with institutional policy, and federal, state, and local regulations governing human subjects research.
  
• Formulates agenda materials and tracks components of the review process, including communication with other offices and committees.
  
• Attends IRB meetings to record information needed to develop study-specific local context questionnaires. Accurately and succinctly summarizes IRB discussions regarding scientific and regulatory matters pertaining to human subjects research.
  
• Independently prepares local context questionnaires in preparation for participating site onboarding.
  
• Maintains a working knowledge of JHM IRB procedures, guidelines and policies for all research, and research subject to review under an IRB reliance agreement.
  
• Assists in drafting and communicating cede determinations to JHU and external investigators for studies where JHM IRB is the reviewing IRB or a relying institution.
  
• Serves as a JHM IRB liaison for external reliance platforms where reliance determinations may be documented.
  
• Tracks reliance agreements and associated letters of indemnification when JHM IRB is the reviewing IRB or relying on an external IRB.
  
• Upon approval of reliance requests, draft letters of support and budget proposals related to sIRB fees.
  
• Works closely with the JHM IRB Budget Analyst to ensure accurate and timely billing of sIRB fees.
  
• Supports JHM IRB staff and member time tracking for time spent on IRB reliance activities.
  
• Assists with the development of educational materials [e.g., presentations, posters] to train and educate PIs, IRB staff, and relying sites.
  
• With the Assistant Director, Reliance Program, creates and maintains operational/training manuals to support investigators with submitting single IRB studies.
  
• With the Assistant Dean, Director of Operations. Assistant Director, Reliance Program, Systems Administrator and others, work with Research Environment Systems (RES) to make improvements to the relevant electronic application submission system(s) to enable processing of submissions where JHM IRB is serving as the single IRB or relying on external IRBs. This will include testing of solutions in development stage and trouble-shooting technical inquiries from study teams.
  
• With the Training Specialist and others, provide training and education for PIs, study teams, IRB members and others on the IRB reliance process.

Special Knowledge Skills & Abilities

• Good analytical and writing skills.
• Knowledge of the ethical principles and regulations relevant to human subjects research and IRB processes.
  
• Demonstrated ability to work independently, exercise sound judgment and multi-task.
  
• Excellent written and verbal communication skills.
  
• Ability to communicate in a professional, positive and persuasive manner.
  
• Ability to work as a team member, be very detailed oriented, and communicate with faculty and staff both internal and external to the institution at all levels.
  
• Strong administrative/coordination skills.
  
• Experience in high volume office and ability to meet time sensitive processing deadlines. Ability to work in fast-paced and demanding environment and able to manage multiple tasks effectively.

Physical Requirements

• Sitting in a normal seated position for extended periods of time.
• Reaching by extending hands or arms in any direction.
  
• Finger dexterity is required to manipulate objects with fingers rather than with whole hands or arms, for example, using a keyboard.
  
• Communication skills using the spoken word.
  
• Ability to see within normal parameters.
  
• Ability to hear within normal range.
  
• Ability to move about, including transportation of a laptop computer and files.
  

*This description is a general statement of required major duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.

• Bachelor's Degree.
• Three years of related human subjects compliance and/or research administrative experience are required.
• Graduate level education and training may substitute for up to two years required experience, to the extent permitted by the JHU equivalency formula.

Classified Title: IRB Analyst
Working Title: IRB Reliance Analyst
Role/Level/Range: ATP/04/PC
Starting Salary Range: $52,230 - $71,890 - $91,550 Annually Commensurate with experience
Employee group: Full Time
Schedule: Monday - Friday 8:30am - 5:00pm
Exempt Status: Exempt
Location: School of Medicine
Department name: SOM Admin Clinical Invest Human Subjects
Personnel area: School of Medicine

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.

The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer

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.

EEO is the Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf

Accommodation Information

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 Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.

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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