Research - Laboratory/Non-Laboratory, Staff/Administrative
IRB Analyst: processes human subjects research documents for JHM Institutional Review Boards (IRB). The individual demonstrates detailed knowledge of the IRB review process and is capable of assuming both pre-meeting and post-meeting responsibilities. This position will be responsible for special projects as needed as well as assume roles and responsibilities for expected and unexpected staff abscences. Assist with workflow coverage during periods of increased volume.
Essential Job Functions
Demonstrates knowledge-based understanding of the complete IRB review process.
Works with minimum supervision to provide administrative and regulatory support and advice regarding human subjects research applications submitted to the IRB.
Conducts administrative and regulatory review of designated human subjects research application submissions.
Determines level of review appropriate for research submission.
Advises & assists investigators and their staff regarding submission of applications in accordance with institutional policy, 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.
Records IRB meeting minutes in keeping with current policies and procedures. Must be able to accurately and succinctly summarize discussions regarding scientific and regulatory matters pertaining to human subjects research.
Independently prepares appropriate correspondence to document the IRB's decision regarding the review of human subjects research applications.
Assist on other projects as needed.
Scope of Responsibility
The IRB Analyst must be able to make sound judgements and take responsibility for independent decisions and actions while following regulatory criteria.
The IRB Analyst is supervised by the Associate Director of Operations.
Communication The IRB Analyst must have excellent written and verbal communication skills. The specialist must have the ability to work as a team member, be very detailed oriented, and have the personality that can adapt to a stressful work environment.
Bachelor's degree and minimum of three years of related human subjects compliance and/or research administrative experience are required. Graduate level training can substitute for up to two years of related experience.
Require good analytical and writing skills. Experience with preparation, submission, or conduct of human subjects research studies required. Experience in high volume office and ability to meet time sensitive processing dates.
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: IRB 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.
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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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