sIRB Reliance Analyst

General Summary

The Institutional Review Board (IRB) Reliance Analyst is part of a team that processes human subjects research protocols overseen by the Johns Hopkins Medicine (JHM) IRB.

Within the scope of the reliance relationships utilizing the single IRB (sIRB) model, JHM participates as both a relying institution and reviewing IRB. The sIRB Reliance Analyst is responsible for providing administrative support and coordination for the reliance process. This position will involve technical and administrative support for reviews conducted under the reliance process.

Essential Job Functions

• Demonstrates knowledge-based understanding of the complete IRB review process.

• Works with minimum supervision to provide support and advice with a specific focus on submissions subject to a reliance agreement.

• 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.

• Process external IRB applications to ensure all local (JHM) consent requirements have been addressed.

• Process sIRB studies where JHM is the reviewing IRB, including pSite consent creation and generation of IRB correspondents.

• Flag applications that request a reliance agreement in eIRB to ensure appropriate tracking of studies associated with a reliance request that is in progress or fully executed.

• Maintains a working knowledge of JHM IRB procedures, guidelines and policies for all research, and research subject to review under an IRB reliance agreement.

• Works closely with the JHM IRB Budget Analyst to ensure accurate and timely billing of sIRB fees.

Scope of Responsibility

The sIRB Reliance Analyst must be able to make sound judgements and take responsibility for independent decisions and actions while following regulatory criteria.

Authority

The sIRB Reliance Analyst reports to the Assistant Director, Reliance Program.

Education

Bachelor’s degree required. Graduate level training can substitute for up to one year of related experience as described below.

Experience

A minimum of two years of related human subjects protections and/or research administrative experience are required. Direct experience working within an IRB office preferred.

Qualifications:

• 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.

Physical Requirements

• Sitting in a normal seated position for extended periods of time.

• Reaching by extending hand(s) or arm(s) in any direction.

• Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s), 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.

Classified Title: IRB Analyst

Working Title: sIRB Reliance Analyst

Role/Level/Range: ATP/04/PC

Starting Salary Range: $26 - $35.78 per hour

Employee group: Part-time

Schedule: M-F 8:30 - 5:00

Exempt Status: Exempt

Location: 04-MD:School of Medicine Campus

Department name: 10002712-SOM Admin Clinical Invest Human Subjects

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 protected] . 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.

Equal Opportunity Employer

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Equal Opportunity Employer:

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.