IRB Compliance Manager
IRB Compliance Manager
Research Compliance -390000
The Office of Research Compliance manages the highly specialized Human Research Protection Program at the University and engages with community members in the regulatory area of human subject research. Within the Office of Research Compliance, this position reports to an Assistant Director of Research Compliance to assure regulatory components are appropriate and in place for review and possible approval by a human subject review committees (IRB). This Department also conducts education, outreach and audits associated with research regulatory compliance.
The Research Compliance Department at the University of North Texas Health Science Center is seeking to hire a IRB Compliance Manager to join our team.
Responsibilities of the position include but are not limited to:
* Assist with development and implementation of human research protection.
* Research compliance education and training program for all research staff and students, including regulatory processes, protection of human subjects, and related conflict of interest issues.
* 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.
* Perform administrative and regulatory review of designated IRB submissions by ensuring the application meets all federal agency regulatory requirements for human subject research and institutional policy.
* Conduct detailed regulatory, procedural and ethical review of biomedical, clinical trial, and social and behavioral science research protocols involving human subjects.
* Prepare documents for review by compliance committees.
* Assist with oversight, attendance and coordination of IRB committee meetings and communicate outcomes to investigators and relevant institutional officials.
The University of North Texas System is firmly committed to equal opportunity and does not permit - and takes actions to prevent - discrimination, harassment (including sexual violence), and retaliation on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity or expression, age, disability, family status, genetic information, citizenship or veteran status in its application and admission processes, educational programs and activities, facilities, and employment practices. The University of North Texas System immediately investigates and takes remedial action when appropriate.
The University of North Texas System also takes actions to prevent retaliation against individuals who oppose a discriminatory practice, file a charge, or testify, assist or participate in an investigative proceeding or hearing.
The successful candidate will possess the following required qualifications:
* Bachelor's degree and four (4) years related experience; or equivalent combination of education and experience.
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
* 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.
Special Instructions to Applicants
Applicants must submit a resume and a cover letter with their online application.
Salary commensurate with experience
Application Types Accepted
Occupational Exposure to HIV/HBV?
Occupational Exposure to Hazardous Chemicals?
Occupational Exposure to Tuberculosis?
Require a valid Texas Driver's License?
Require a certification?
Official Job Title
Job Open Date
Job Close Date
Open Until Filled