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IRB Analyst

Employer
Johns Hopkins University
Location
Maryland, United States
Salary
Salary Not Specified
Date posted
Mar 4, 2021

General Summary

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.

Authority

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.

Education

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.

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.

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: 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.

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 atjhurecruitment@jhu.edu. 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
Note: Job Postings are updated daily and remain online until filled.

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

School of Medicine - East Baltimore Campus


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 jhurecruitment@jhu.edu. 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
Note: Job Postings are updated daily and remain online until filled.

EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm

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