Program Specialist

The UNM Clinical and Translational Science Center (CTSC) is seeking a knowledgeable, detail-oriented Regulatory Affairs Specialist to oversee the operational planning, establishment, execution, and evaluation of HSC regulatory compliance for the Primary Care--Building Research Integration in Diverse Geographic Environments (PC-BRIDGE) Network Research Hub. The Regulatory Affairs Specialist will serve as a member of a multi-disciplinary team conducting human subjects' research. Work is performed under the general supervision of the Senior Program Manager.

The PC-BRIDGE Network Research hub is organized to be grounded in New Mexico's long-standing CTSA and partnered with primary care practices in service of rural and underrepresented populations. PC-BRIDGE's experienced team includes primary care clinical partners who are well poised to extend research participation opportunities to NM communities often underrepresented in clinical research and to integrate those opportunities into the routine primary care clinical settings where people seek care. This team will be part of the national coordinated infrastructure as a primary care research hub.

Duties and responsibilities:

* Work directly with PC-BRIDGE leads to ensure timely and accurate regulatory support for study activities at community primary care clinics that are part of the UNM Hub site.

* Collaborate with lead site team members of the TAICHIKNEE and SUPERA studies to assure timely submission of all IRB documentation and other regulatory requirements.

* Ensure compliance with institutional and parent regulatory bodies for all projects.

* Obtain regulatory approvals and communicate with other sites for PC-BRIDGE.

* Maintain regulatory files for TAICHIKNEE and SUPERA.

* Respond to regulatory authorities' questions with assigned timeline.

* Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports, deviations, and review of safety reports. Establishes and maintains processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations.

* Serves as primary contact for each assigned trial, maintains records, assists with reporting, and corresponds with all parties involved (institutional, federal, parent sites).

* Provides direction and feedback to research team to ensure awareness of business practices and quality standards.

* Completes submission applications, and other required documentation, and prepares protocol specific forms for submission to various review committees, including the local IRB and sponsoring entities.

* Complete regulatory requirements necessary for development of any new studies for this primary care initiative.

* Attends research team meetings to report on regulatory issues.

* Perform miscellaneous job-related duties as assigned.

TERM APPOINTMENT; FUNDING AVAILABLE THROUGH 01/31/2026; CONTINUANCE BEYOND THAT DATE SUBJECT TO AVAILABILITY OF ADDITIONAL FUNDING.

See the Position Description for additional information.

• Employees who provide services or work in patient care or clinical areas are required to be in compliance with the University's influenza vaccination requirement.
• If located at the UNM Children's Campus, successful candidate must pass a comprehensive post-offer, pre-employment criminal and New Mexico Children, Youth and Families Department (CYFD) fingerprint background check, and a continued successful status will be verified by periodic future background checks.

High school diploma or GED; at least 6 years of experience directly related to the duties and responsibilities specified.

Completed degree(s) from an accredited institution that are above the minimum education requirement may be substituted for experience on a year for year basis.

• Knowledge of regulatory policy and procedures related to Human Subject Research and multisite trials
• Knowledge of Huron IRB
• Bilingual in English and Spanish
• Undergraduate degree

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Positions posted with a Staff Type of Regular or Term are eligible for the Veteran Preference Program. See the Veteran Preference Program webpage for additional details.

The University of New Mexico is committed to hiring and retaining a diverse workforce. We are an Equal Opportunity Employer, making decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran status, disability, or any other protected class.

The University of New Mexico requires all regular staff positions successfully pass a pre-employment background check. This may include, but is not limited to, a criminal history background check, New Mexico Department of Health fingerprint screening, New Mexico Children, Youth, and Families Department fingerprint screening, verification of education credentials, and/or verification of prior employment. For more information about background checks, visit https://policy.unm.edu/university-policies/3000/3280.html. Refer to https://policy.unm.edu/university-policies/3000/3200.html for a definition of Regular Staff.