Exempt/Expedited Analyst
- Employer
- Johns Hopkins University
- Location
- Maryland, United States
- Salary
- Salary Not Specified
- Date posted
- Jun 21, 2021
View more
- Position Type
- Administrative, Academic Affairs, Research Administration, Business & Administrative Affairs, Business & Administrative Support
- Employment Type
- Full Time
-
Demonstrates knowledge-based
understanding of the complete IRB review process and is capable of
assuming both pre-meeting and post-meeting
responsibilities.
-
Works with minimum
supervision to provide administrative and regulatory support and
advice regarding human subjects research applications submitted to
the IRB.
-
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.
-
Independently prepares appropriate
correspondence to document the IRB’s decision regarding the review
of human subjects research applications.
-
Supports investigators and
study teams in creating research applications that may qualify for
exempt/expedited review.
-
Advises IRB reviewers [staff
and Board members] making determinations of federally mandated
minimal risk review categories.
-
Creates training materials
for the screening and reviewing of exempt and expedited research to
support staff and Board member reviewers
-
Serves as an office-wide
resource to support staff, Board members and the research community
in the submission and review of exempt and expedited research
applications.
-
Provides application
screening assistance with regulatory and administrative
pre-reviews, as well as post-IRB processing as
needed.
-
Independently conducts
review of new research applications [and their subsequent further
study actions] and works with faculty/research staff to identify
deficiencies needing correction prior to IRB review and/or
approval.
-
Determines conditions for
protocol-specific documentation for waiver of consent, waiver of
HIPAA authorizations and additional regulatory determinations are
met according to regulatory requirements.
-
Assists on other projects as
needed.
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.
*This position has been designated as a remote position. On-site attendance may be required for select meetings or events. Advanced notice will be provided for these circumstances.*
Classified Title:IRB Analyst
Working Title: Exempt/Expedited
Analyst
Role/Level/Range: ATP/04/PC
Starting Salary Range:$50,700 -
$69,780
Employee group: Full 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
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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