Research Compliance Coordinator

Title : Research Compliance Coordinator

Employee Classification : Research Compliance Coord

Campus : University of North Texas - Health Science Center

Division : HSC-Div of Rsrch & Innovation

SubDivision-Department : HSC-Div of Rsrch & Innovation

Department : HSC-Rsrch Compliance-390000

Job Location : Fort Worth

Salary : Commensurate with Experience

FTE : 1.000000

Retirement Eligibility : TRS Eligible

About Us - Values Overview :

Welcome to the University of North Texas System. The UNT System includes the University of North Texas in Denton and Frisco, the University of North Texas at Dallas and UNT Dallas College of Law, and the University of North Texas Health Science Center at Fort Worth.

We are the only university system based exclusively in the robust Dallas-Fort Worth region. We are growing with the North Texas region, employing more than 14,000 employees, educating a record 49,000+ students across our system, and awarding nearly 12,000 degrees each year.

We are one team comprised of individuals who are committed to excellence, curiosity and innovation. We are transforming lives and creating economic opportunity through education.

We champion a people-first values-based culture where We Care about each other and those we serve. We believe that we are Better Together because we foster an inclusive environment of respect, belonging, and access for all.

We demonstrate Courageous Integrity through setting exceptional standards and acting in the best interest of our communities.

We are encouraged to Be Curious about opportunities for learning, creating, discovering, and innovating, and are encouraged to learn from failure.

Show Your Fire by joining our team and exhibiting your passion and pride in your work as part of our UNT System team.

Learn more about the UNT System and how we live our values at www.UNTSystem.edu .

Department Summary

The Office of Research Compliance (ORC) at the University of North Texas Health Science Center is located within Research Administration and the Division of Research.

The ORC works with offices responsible for specific components of research compliance and university research oversight committees such as the Institutional Review Board, Institutional Biosafety, Institutional Animal Care and Use, Research Conflict of Interest committees and the Export Control Office to ensure the responsible conduct of research and compliance with university policies and federal regulations related to research activity.

The office oversees development and implementation of policies, procedures, and educational activities which satisfy university policies, state, and federal regulations governing the conduct of research.

The ORC is responsible for monitoring regulatory updates and making recommendations to the university to ensure compliance.

Position Overview

The Office of Research Compliance (ORC, which includes the North Texas Regional Institutional Review Board NTR IRB, the Institutional Animal Care and Use Committee IACUC, Research Conflict of Interest Committee RCOI, Export Controls Office, in addition to Research Integrity RI), is seeking to hire a Research Compliance Coordinator to join our team.

This position will report directly to the Executive Director of the ORC and will help with maintaining a culture of compliance for our HSC research community.

Minimum Qualifications

Bachelor's degree in a life science discipline or related field and four (4) years of related experience; or equivalent combination of education and experience.

Knowledge, Skills and Abilities

• Strong interpersonal skills (listening skills, problem-solving, confidence, etc.)
• Basic knowledge of appropriate federal regulatory agencies (FDA, OHRP, PHS, NIH, OLAW, USDA, etc.,)
• Ability to multitask with emphasis on customer service.
• Well-developed organizational and analytical skills; outstanding attention to detail; objective observer.
• Exceptionally strong written communication, verbal communication, and presentation skills; education and training experience in higher education preferred.
• Skill set in working in electronic databases / submission systems, websites / web pages, and online outreach and training tools;
• High level of maturity, diplomacy, integrity, and strict confidentiality.

Preferred Qualifications

The preferred candidate will possess the following additional qualifications :

• Bachelor’s degree in any health sciences field.
• 2-4 years human subject research experience or 4 years in research compliance related role.
• Certified IRB Professional (CIP) Certification, Certified Professional in IACUC Administration (CPIA), or eligibility for such certification or similar.
• 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 / Certifications

None

Job Duties :

15% - Responsible for carrying out daytoday actions for RCOI, which includes following up with researchers as needed for any discrepancies found in submitted RCOI disclosures and forwarding any potential issues to ORC Director and RCOI Chair for review and discussion.

Regular duties also include maintaining management plans for any researchers in which a conflict exists, and working with the RCOI Committee Chair on preparing any new management plans (as appropriate).

Additionally, the incumbent is responsible for maintaining the RCOI website, and ensuring all information remains current - (Essential)

• 5% - Work in conjunction with HSC Institutional Compliance regarding COI disclosures. This includes reviewing all RCOI disclosures for any potential conflicts (either personal or financial), as well as helping Institutional Compliance to maintain the electronic COI submission system. - (Essential)
• 15% - Coordinate monthly RCOI committee meetings, which includes the following : preparing meeting agenda and related materials and distributing to board members prior to the meeting;
• meeting with RCOI Chair and ORC Director prior to meeting to help facilitate / organize discussion items; tracking attendance / quorum during meeting and taking appropriate notes;

drafting detailed minutes postmeeting; drafting letters and communicating findings back to investigators / researchers. - (Essential)

15% - Develop and maintain indepth knowledge of the federal regulatory framework governing human subjects research (Office for Human Research Protections OHRP, U.

S. Food and Drug Administration FDA, etc.), animal research (Office of Laboratory Animal Welfare OLAW, U.S. Department of Agriculture USDA, Guide for the Care and Use of Animals, etc.

research conflict of interest (Public Health Service PHS, National Institutes of Health NIH, National Science Foundation NSF, etc.

research misconduct (Office of Research Integrity ORI), and responsible conduct of research. - (Essential)

20% - For the HSC Human Research Protection Program, the incumbent will maintain a list of investigators / studies which have an active Corrective Action Plan in place (as a result of noncompliance from an audit, routine IRB review, or selfreported) and will followup with investigators / study teams to ensure plans are working as intended.

The Incumbent will be expected to work with ORC Director and the NTR IRB Director and team to identify when adjustments to plans might be needed. - (Essential)

15% - As needed, assist the IACUC, the North Texas Regional IRB, and the Export Controls office with routine reviews of protocols (for IACUC and IRB) along with risk assessments for international travel (Export Controls / International Compliance).

Assistance with accreditation efforts and maintaining documentation for both the human research and animal research programs may be required.

Other types of reviews may be expected of the incumbent, depending on office needs. - (Essential)

15% - Work closely with the ORC Executive Director and the Education Outreach Specialist on training, outreach, and communications to facilitate regulatory compliance, foster a culture of research integrity, promote responsible conduct of research initiatives, and provide regulatory expertise guidance to support the HSC research community. - (Marginal)

Work Schedule : M-F, 8a-5p

M-F, 8a-5p

Driving University Vehicle :

Security Sensitive :

This is a Security Sensitive Position.

Special Instructions :

Benefits :

For information regarding our Benefits, click here .

EEO Statement :

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, genetic information, 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 complaints of discrimination and takes remedial action when appropriate.

The University of North Texas System also takes actions to prevent retaliation against individuals who oppose any form of harassment or discriminatory practice, file a charge or report, or testify, assist or participate in an investigative proceeding or hearing.