The Homewood IRB and Conflict of Interest Office is seeking an IRB Analyst who plays supportive role in implementing the activities of the Office including initial processing of all documents submitted for review and approval. Serves as a resource to investigators campus wide. The HIRB serves the Krieger School of Arts and Sciences, Whiting School of Engineering, School of Education, Carey Business School, Nitze School of Advanced International Studies, and Peabody Institute. HIRB is responsible for reviewing all research projects involving human participants conducted in these divisions.
Specific Duties & Responsibilities:
IRB/Research Compliance Support (95%)
Provide pre-review for incoming IRB research applications, determine adequacy of IRB applications and level of review required, select reviewers for protocol reviews, follow-up with IRB reviewers to assure appropriate level of review provided, and prepare approval letters and finalized documents through eHIRB
Provide guidance to research team members regarding the IRB submission process, and assists researchers with the development of an IRB application and/or informed consent documents
Support and document all IRB meetings with agendas, meeting minutes, and other relevant materials
Perform quality assurance reviews to ensure compliance with IRB policies and federal regulations, including audits, protocol and informed consent review, and recordkeeping review
Provide training and act as internal consultant to staff, IRB committee members, and the JHU research community
Assist in revising IRB and human subject research policies and procedures
Conduct testing of the electronic HIRB system to identify problems and bugs
Assist with updating the IRB website
Perform routine database queries and report generation, including a monthly expedited report
Monitor the Office's general HIRB email inbox and respond to requests for information, complaints, and concerns
Support the Homewood Conflict of Interest and Commitment Program, on as needed basis
Administrative Support (5%)
Oversee and monitor budgetary actions
Reconcile monthly expenses
Purchase supplies, equipment and services for office operation
Maintain journal subscriptions
Distribute journals to IRB members
Other duties as assigned
Minimum Qualifications (Mandatory):
Three years of related human subjects compliance and/or research administrative experience
Graduate level training can substitute for up to two years of related experience.
* 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.
Three years of IRB regulatory experience, preferably in an academic setting
Certified IRB Professional (CIP) credential
Special Knowledge, Skills & Abilities:
Proficiency with Microsoft Office Suite and Outlook required
Working knowledge of the federal regulations related to IRB and human subject research subjects
Knowledge of PHS regulations related to promoting objectivity in research preferred
High level of organizational skills and time management and strong analytical reasoning skills
Can work with limited supervision, makes decisions and establishes work priorities on essentially procedure-oriented operations
Must be service-oriented and able to interact effectively with individuals at all levels of the organization
Excellent written and oral communication skills
Ability to maintain high level of confidentiality
Technical Qualifications or Specialized Certifications:
Certified IRB Professional (CIP) credential
Classified Title: IRB Analyst Role/Level/Range: ATP/04/PC Starting Salary Range: $51,210 - $70,480 annually (commensurate with experience) Employee group: Full Time Schedule: M-F, 8:30 a.m. to 5 p.m. Exempt Status: Exempt Location: ???????Homewood Campus Department name: ???????Dean Office of Personnel area: School of Arts & Sciences
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 firstname.lastname@example.org. For TTY users, call via Maryland Relay or dial 711.
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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