Deadline: Open until filled

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General Description:

The University of North Carolina at Chapel Hill is recruiting to fill the position of Quality Improvement/Assurance Manager.

The Office of Human Research Ethics (OHRE) is responsible for ethical and regulatory oversight of research at UNC-Chapel Hill that involves human subjects. OHREadministers, supports, guides and oversees the work of the Institutional Review Boards (IRBs), and all related activities. These IRBs are federally mandated review committees, operating under regulations from the Office for Human Research Protections (OHRP, DHHS) and the Food and Drug Administration (FDA). The OHRE and IRBs are critical components of a program that serves to protect the rights and welfare of human research subjects. All components of this program, coordinated through the OHRE, must work together to ensure institutional compliance with ethical principles and regulatory requirements.

Additionally, in accordance with the mission of OHRE, the goals are to ensure compliance with federal regulations and university policy, and to promote best practices in human research protections. This can best be accomplished by consistent application of policies and procedures and standardized documentation of IRBactions.

The Quality Improvement/Assurance Manager reports to the Director of the Office of Human Research Ethics and through the Director to the Associate Vice Chancellor for Research Compliance and through to the Vice Chancellor for Research. S/he will be responsible for developing and implementing a program for monitoring OHRE quality and performance at an operational level and for the generation and implementation of corrective and preventative action (CAPA) plans in order to facilitate a high level of quality and compliance.

The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.

Requirements and Qualifications:

Educational Requirements: Relevant post-Baccalaureate degree required; for candidates demonstrating comparable independent research productivity or professional-level background in sponsored research administration, will accept a relevant undergraduate degree and 3 or more years of relevant experience in substitution.

Qualifications and Experience: Minimum of 3 years’ of human subject’s protection /IRBexperience with knowledge of the federal regulations required. Experience with quality assurance/improvement methods preferred.

Additional required qualifications include:

  • Must exercise high degree of independent judgement and discretion.
  • Leadership skills and ability to relate to a diverse group of individuals within the office and across campus.
  • Excellent interpersonal skills as well as effective verbal and written communication skills.
  • Evidence of self-motivation and the ability to work both independently and as part of a team.
  • Strong organizational, problem solving and critical thinking skills.
  • Demonstrates self-motivation, initiative, diplomacy, and professional demeanor.
  • Detail-oriented.

Preferred Qualifications and Experience: Certification as IRB Professional (CIP).

To Apply for this position, please visit the provided link to access position 01002459:

Learn more and apply here!

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