Position Details

UNT System Overview

Welcome to the University of North Texas System, or UNT World as we like to call ourselves. UNT World includes the University of North Texas in Denton, the University of North Texas at Dallas and the University of North Texas Health Science Center in Fort Worth. We are the only university system based exclusively in the robust Dallas-Fort Worth region and we are committed to transforming lives and creating economic opportunity through education. Over the past decade, combined UNTS enrollment has grown by more than 25 percent to nearly 44,000 students.

Posting TitleIRB Compliance ManagerDepartmentHSC-Rsrch Compliance-390000Job LocationFort WorthFull Time/Part TimeFull-TimeSalary InformationSalary Commensurate with ExperienceDepartment Summary

The Office of Research Compliance at the University of North Texas Health Science Center is seeking to hire an IRB Compliance Manager to join our team. This position is responsible for providing support to the North Texas Regional Institutional Review Board, within the Office of Research Compliance, in the Division of Research and Innovation.

Position Overview

The Office of Research Compliance (ORC) at the University of North Texas Health Science Center, in conjunction with the North Texas Regional Institutional Review Board (NTR IRB), is seeking to hire an IRB Compliance Manager to join our team. This position will report directly to the Director of the NTR IRB and will also work closely with the ORC. Responsibilities include (but are not limited to) the following:

*Assist with development and implementation of human research protection for all NTR IRB partners; *Perform comprehensive administrative and regulatory reviews of designated IRB submissions (which include biomedical, clinical trial, and social/behavioral science studies) by ensuring applications/submissions meet all federal agency regulatory requirements for human subject research; *Ongoing education and training for all researchers to ensure appropriate compliance with federal, state and university/institutional policies and regulations associated with human subject research; *Prepare documents for review by the IRB reviewers/committee;
*Assist with oversight, attendance and coordination of IRB committee meetings and communicate outcomes to investigators and relevant institutional officials;
*Assist with development and roll- out of in-house compliance training programs, workshops, seminars and other outreach and educational tools and training related to IRB and human subject research.
*Assist in the daily activities and operation of the NTR IRB.

Minimum Qualifications

Bachelor’s degree and four (4) years related experience; or equivalent combination of education and experience.

Knowledge, Skills and Abilities

• Thorough knowledge of appropriate federal regulatory agencies (FDA, OHRP)
• Skill set in development and update of web sites, web pages and on-line outreach and training tools
• Well-developed organizational and analytical skills; outstanding attention to detail; objective observer.
• Exceptionally strong written, verbal, and presentation skills; adult education and training experience.
• High level of maturity, diplomacy, and strict confidentiality.

Preferred Qualifications

The preferred candidate will possess the following additional qualifications:
*Bachelor’s degree in any health sciences field, Master’s Degree preferred.
*3 years’ human subject research experience or 3 years in an IRB-related role.
*Certified IRB Professional (CIP) Certification or eligibility for such certification.
*Prior experience with critical thinking, project management, document management and client interactions.
*1-3 years across all categories in hospital research setting, university, or clinical research operation.

Required License / Registration / CertificationWork Schedule

M-F 8-5

Driving University VehicleNoSecurity SensitiveThis is a security sensitive positionEEO Statement

The University of North Texas System and its component institutions are committed to equal opportunity and comply with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University of North Texas System and its component institutions do not discriminate on the basis of race, color, sex, sexual orientation, gender identity, gender expression, religion, national origin, age, disability, genetic information, or veteran status in its application and admission processes, educational programs and activities, and employment practices.

Classification TitleCompliance ManagerPhysical RequirementsLifting up to 10 pounds, Sitting, Standing, Walking, Writing, Talk or Hear Job Duties

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Assist NTR IRB Director with daily IRB operations, which includes development and implementation of human research protection for all NTR IRB partners (includes researchers from UNTHSC, John Peter Smith Health Network, University of North Texas at Dallas, and Cook Children’s Hospital). This position will work directly with researchers/investigators from all organizations (as needed), and will also work closely with the IRB Committee (Chair and Board members) and fellow IRB Compliance coordinators.

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Perform comprehensive administrative and regulatory reviews of designated IRB submissions (which include biomedical, clinical trial, and social/behavioral science studies) by ensuring applications/submissions meet all federal agency regulatory requirements (e.g., Office for Human Research Protections [OHRP]; Food and Drug Administration [FDA]) for human subject research. This includes review of new submissions, in addition to continuing reviews, amendments, reportable events, etc. Additionally, this position will also ensure all institutional policies/procedures regarding human subject research are met, in addition to any other state and local regulations/policies.

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Ongoing education and training for all researchers/investigators to ensure appropriate compliance with federal, state and university/institutional policies and regulations associated with human subject research. The incumbent is expected to be knowledgeable and stay up-to-date regarding federal, state, and local/institutional regulations/policies/guidance.

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Prepare documents for review by the IRB Committee. This may include (but are not limited to) preparation of comments and pre-review notes for Board Member review, in addition to following-up with researchers/investigators on information needed in preparation of discussion at IRB meetings.

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Assist with oversight, attendance and coordination of IRB committee meetings and communicate outcomes to investigators and relevant institutional officials. This also includes (but not be limited to) preparing meeting agendas, setting up for IRB meetings, tracking attendance/quorum during meetings, and drafting detailed meeting minutes (which adhere to all federal regulatory requirements)

o

Assist the NTR IRB Director, in addition to the ORC Director (as needed), with development and roll- out of in-house compliance training programs, workshops, seminars and other outreach and educational tools and training related to IRB and human subject research. This may include preparation of educational/training documents, procedure manuals, or presentations to investigators or other key stakeholders.

Posting NumberS960PPosition End Date (if temporary)Special Instructions to ApplicantsQuicklink for Postinghttp://jobs.untsystem.edu/postings/38228Supplemental Questions

Required fields are indicated with an asterisk (*).

1. * Do you have a bachelor's degree?
   • Yes
   • No
2. * How many years of experience do you have in this type of position?
   • 0-1
   • 1-3
   • 3-5
   • 5-7
   • 7+
3. * What is your highest level of education attained?
   • GED
   • High School Diploma
   • Associate's Degree
   • Bachelor's Degree
   • Master's Degree
   • Doctorate

Documents Needed to ApplyRequired Documents

1. Resume
2. Cover Letter
3. List of Names and Contact Information for 3 references

Optional Documents