The University of New Mexico Health Sciences (UNM HS) Office of Research is seeking a knowledgeable, respected, goal-driven leader to join our team as a Human Protections Specialist, specializing in quality assurance and quality improvement. The successful candidate will have experience in providing direction and administrative oversight to all core components of the institution's Human Research Protection Program (HRPP) including Institutional Review Board (IRB), Training, Quality Assurance and Improvement. The Human Protections Specialist will assist the UNM HS Executive Leadership in overseeing the facilitation and support of research reviewed by three IRBs including the development and implementation of program goals and objectives. 

The institution's HRPP is a comprehensive system to ensure the protection of the rights and welfare of subjects involved in human research and is accredited by the Association for the Accreditation of Human Research Protections Programs (AAHRPP). The Human Research Protections Office supports three IRBs. The office promotes the safety and protection of individuals involved in human research by providing support, guidance and education to facilitate ethical and scientifically sound research. 

Specific Duties and Responsibilities include:

1.Plans, develops, implements, and coordinates the HRPP program with primary focus on Quality Assurance and Quality Improvement.

2.Conducts for-cause and random on-site audits and assists investigators in quality improvement activities.

3.Provide leadership and guidance for the team performing Pre- and Post-Review of studies submitted for review by the IRB. Oversee, provide, and coordinate technical and administrative review of human research application materials for review by the IRB.

4.Closely align team processes and resources to meet goals and objectives of the unit.

5.Provide day-to-day supervision and oversight for the IRB operational workflow of the HRPP with primary focus on Quality Assurance and Quality Improvement.

6.Designs, establishes, and maintains the HRPP staffing and an organizational structure to effectively accomplish the HRPP program function; will train, supervise, and evaluate HRPP program.

7.Develops and implements systems and processes to establish and maintains common office practices for the HRPP.

8.Supervises and engage in outreach with the research community; may produce and/or market project(s) and/or process improvement(s).

9.Work closely with the UNM HS Executive Leadership and other members of Senior Leadership to identify and plan program improvements.

10.May represent the university to various institutional divisions as well as externally to governmental agencies, funding agencies, national organizations, and the general public.

11.Provide support and guidance to investigators on content submitted for review by the IRB.

12.Supervises ongoing efforts to maintain accreditation.

13.Works with Senior Leadership to establish performance goals, and then produces and monitors performance metrics.

14.Trains and supervises staff on various duties and responsibilities for back-up support.

15.Performs miscellaneous duties as necessary.

See the Position Description for additional information.

• For HSC positions: Certification as Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), or Certified IRB Professional (CIP) must be obtained within 1 year of date of hire.

Bachelor's degree in Nursing, Biomedical Science, or closely related field; at least 3 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.

·Bachelor’s Degree

·Demonstrated work experience with increasing responsibility in a human subjects protection program.

·Experience in an HRPP at a research university.

·Experience supervising or conducting human research.

·Knowledge of AAHRPP standards and accreditation requirements.

·Knowledge of HIPAA regulations and state laws governing privacy.

·Demonstrated leadership experience.

·Demonstrated supervisory and operational experience.

·Experience preparing applications and other documents for submission to an Institutional Review Board (IRB).

·Experience monitoring or coordinating human research activities in a clinical setting or in an IRB setting.

·Direct experience in IRB Administration.

·Experience using an electronic IRB submission program. Experience with Huron IRB (formerly called Click IRB) is a plus.

Only applications submitted through the official UNMJobs site will be accepted. If you are viewing this job advertisement on a 3rd party site, please visit UNMJobs to submit an application.

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.