• Job Description

  Req#: 259264

  Department

  Clinical Research Compliance-621200

  Career Area

  Research Professionals

  Posting Open Date

  04/25/2023

  Application Deadline

  06/30/2023

  Open Until Filled

  No

  Position Type

  Permanent Staff (EHRA NF)

  Working Title

  Senior Director, Clinical Research Compliance

  Appointment Type

  EHRA Non-Faculty

  Position Number

  20054892

  Vacancy ID

  NF0006910

  Full Time/Part Time

  Full-Time Permanent

  FTE

  1

  Hours per week

  40

  Position Location

  North Carolina, US

  Hiring Range

  Dependent on Qualifications

  Proposed Start Date

  07/10/2023

  Primary Purpose of Organizational Unit

  The core purpose of the Office of Clinical Trials (OCT) to ensure compliance with federal, state and institutional requirements by performing the following functions:
  - Supporting the Human Research Protection Program by conducting post IRB approval of clinical studies through the Clinical Trials Quality Assurance (CTQA) program
  - Ensuring correct clinical trial billing of research subjects through the Research Billing Compliance Program
  - Ensuring compliance with the ClinicalTrials.gov registration results reporting
  - Ensuring compliance by reviewing the billing coverage analysis, fully executed agreement, and IRB approved consent form for congruency and accuracy
  - Coordinating the Scientific Review Committee and serving as a resource for protocol development for the research community
  - Serving as the point of contact for questions or issues related to clinical trials
  - Developing and implementing programs and initiatives to enhance the quality of clinical research and support regulatory compliance, through the implementation of the OnCore clinical trials management system enterprise wide
  - Providing education, consultation and guidance on the conduct of clinical trials as requested

  Position Summary

  Under the supervision of the UNC Health System VP Research Officer and the Office of the Vice Chancellor for Research (OVCR), Assistant Vice Chancellor- Clinical Research, and the UNC School of Medicine (SOM) Clinical Research Integration Officer, the Senior Director Clinical Research Compliance is the responsible leader for the alignment of clinical research compliance issues, concerns, investigations, guidelines, standards, policies, education, training, and practices between UNC-CH and UNC Health, with regulatory standards. In addition, the Senior Director Clinical Research Compliance will supervise assigned clinical research compliance staff at the UNC-CH OVCR, UNC-CH SOM, and UNC Health. The Senior Director Clinical Research Compliance is expected to work collaboratively with peer leaders across UNC-CH and UNC Health.

  Minimum Education and Experience Requirements

  Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity or professional-level background in sponsored research administration, will accept a relevant Bachelor’s degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution.

  Required Qualifications, Competencies, and Experience

  - Ten (10) years of Research compliance experience or related functionality.
  - Understands and applies principles, procedures, requirements, regulations, and policies related to specialized expertise.

  Preferred Qualifications, Competencies, and Experience

  - A Master’s degree in an appropriate discipline is preferred.
  - Research/Compliance certification, Clinical licensure, or Leadership certification is highly recommended.

  Campus Security Authority Responsibilities

  Not Applicable.

  Quick Link

  https://unc.peopleadmin.com/postings/255135

  Office of Human Resources Contact Information

  If you experience any problems accessing the system or have questions about the application process, please contact the Office of Human Resources at (919) 843-2300 or send an email to employment@unc.edu
  Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.

  Equal Opportunity Employer Statement

  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.

• About the company

  The University of North Carolina at Chapel Hill is a public research university in Chapel Hill, North Carolina.

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