IRB Review Board Spec. - Institutional Review Board - INTEGRIS
Company: INTEGRIS Health
Location: Oklahoma City
Posted on: April 8, 2021
IRB Review Board Specialist NE
Job Code: 8526
Responsible for conducting in depth reviews of submissions to the
INTEGRIS Health Institutional Review Board using advanced
regulatory knowledge. This includes the review of new protocols,
continuing reviews, modifications to existing protocols, study
closures, emergency use requests, exempt studies, expedited review
and review of any Unanticipated Problems involving Risks to
Subjects or Others. The role works closely with other IRB officers
of administration to ensure uniformity of reviews and compliance
with the Institutional Review Board (IRB) standard operating
procedures as well as applicable federal and state regulations.
This position is the system point of contact for IRB related
processes and procedures and is responsible for vetting documents
to the responsible party. This position works closely with the IRB
Chair and members to provide education, meeting schedules, and
agenda. Under the direction of the System Director of Research,
this position is key in communicating new information related to
the Protection of Human Subject in Research. This position serves
as a liaison between the reviewer and investigator/study team. This
position is responsible for the financial oversight of the IRB
including invoicing of payments, tracking payments, tracking exempt
payments, and reporting write offs related to community
INTEGRIS Health is an Equal Opportunity/Affirmative Action
The Institutional Review Board Specialist responsibilities include,
but are not limited to, the following:
* Serves as the primary point of contact for all activities
requiring review by the Institutional Review Board; performs
preliminary reviews and determines appropriate course of
* Advises physicians and staff regarding instructions, policies and
procedures, and electronic submission processes of applications
through the IRB-Plus system.
* Reviews all submissions for accuracy and compliance with the
policies, provisions, and applicable regulations as required by IH,
OHRP, DHHS, TJC, and FDA.
* Creates a combined PDF file for each application submitted by
combining all documents within that application. Distributes
combined PDF file to appropriate reviewer.
* Reviews subject informed consent documents making sure that all
applicable internal and external requirements have been met.
* Coordinates aspects of the monthly convened IRB meetings
including preparation and distribution of the meeting agenda and
Administrative Review Reports. Attends the IRB Monthly Meeting and
records the decision making process of the IRB Board in official
* Apprises investigators and research team on the IRB decisions,
approvals, changes, additional information, and similar issues and
monitors the status of outstanding issues through resolution.
* Maintains required documentation for IRB members and updates
roster as needed.
* Maintains the research subjects' enrollment database for tracking
and coordination for billing purposes.
* Maintains updated training and education requirements of
Investigators, Sub-Investigators and Study Coordinators.
* Prepares invoices for IRB services and tracks receipt of
Reports to the System Director of the Office of Research and Grant
Required Physical Demands (Subject to Reasonable
Keyboarding/Dexterity: Constantly; activity exists 2/3 or more of
Standing/Walking: Frequently; activity exists from 1/3 to 2/3 of
Strength (Lift/Carry/Push/Pull): Light (Exerting up to 20 pounds of
force occasionally, or up to 10 pounds of force frequently)
Talking (Must be able to effectively communicate verbally): Yes
Color Acuity (Must be able to distinguish and identify colors):
This position may have additional or varied physical demand and/or
respiratory fit test requirements. Please consult the Physical
Demands Project SharePoint site or contact Risk Management/Employee
Health for additional information.
Normal office environment.
All applicants will receive consideration regardless of membership
in any protected status as defined by applicable state or federal
law, including protected veteran or disability status.
* Bachelors degree in Business Administration, Education or a
* Certified IRB Professional (CIP) preferred.
* Must be able to communicate effectively in English
Keywords: INTEGRIS Health, Oklahoma City , IRB Review Board Spec. - Institutional Review Board - INTEGRIS, Other , Oklahoma City, Oklahoma
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