Regulatory Assistant

University of North Carolina- Chapel Hill

United States

November 29, 2021


Posting Information Department Lineberger Compr Cancer Center-426801

Career Area Research Professionals Is this an internal only recruitment? No Posting Open Date 11/19/2021 Application Deadline 11/29/2021 Position Type Permanent Staff (SHRA) Position Title Soc/Clin Research Assistant - Journey Salary Grade Equivalent GN08 Working Title Regulatory Assistant Position Number 20040967 Vacancy ID P013954 Full-time/Part-time Permanent/Time-Limited Full-Time Time-Limited If time-limited, estimated duration of appointment Three years Hours per week 40 Work Schedule

Monday – Friday, 8:00AM – 5:00PM

Work Location Chapel Hill, NC Position Location North Carolina, US Hiring Range $40,945 - $53,000 Pay Band Information

To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.

Primary Purpose of Organizational Unit

The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing of North Carolinians, and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research. We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability. We optimize our partnership with the UNC Health System through close collaboration and commitment to service. OUR VISION Our vision is to be the nation's leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding. OUR MISSION Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research. Patient Care: We will promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond. Education: We will prepare tomorrow's health care professionals and biomedical researchers by facilitating learning within innovative curricula and team- oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce. Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.

Position Summary

This position is time-limited. The primary purpose of this position is to provide para-professional support within the Office of Clinical Translational Research collaborating with the Regulatory staff of the Lineberger Clinical Protocol Office. The Regulatory Assistant gathers, edits, analyzes, and reports data/information for the purposes of communicating with the Institutional Review Board (IRB) and research sponsors. This work is performed in order to comply with federal, state, and local laws, regulations, and guidance applicable to the conduct of oncology clinical research. The Regulatory Assistant participates in the collection, compilation, and management of data/information. The Regulatory Assistant is responsible for quality assurance and quality control; analysis by statistical or other means; generation/production of new data/information; and editing and formatting of reports. The Regulatory Assistant is expected to use considerable sound judgment and their effective research skills in performing their work assignments. Work may include the training and supervision of staff, students and others.

Minimum Education and Experience Requirements

Bachelor's degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Required Qualifications, Competencies, and Experience

Working knowledge and facility with information technology; ability to organize, record, and present information; to lead exchange of information through dialog, instruction, and demonstration; ability to develop working knowledge of regulatory compliance and procedures relating to oncology clinical research; ability to communicate professionally both verbally and in writing. Requires being at a computer for extended periods of time.

Preferred Qualifications, Competencies, and Experience

Knowledge of regulatory policy relating to clinical research and institutional review boards.

Required Licenses/Certifications Special Physical/Mental Requirements

Ability to lift/move 25 pounds, with or without accommodations. Ability and willingness to push cart with files between 4-5 buildings, with or without accommodations.

Campus Security Authority Responsibilities

Not Applicable.

Position/Schedule Requirements Evening work occasionally, Overtime occasionally, Weekend work occasionally Special Instructions Quick Link https: //

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

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, race, national origin, religion, sex, sexual orientation, or status as a protected veteran.

Applicant Documents

Required Documents

  • Curriculum Vitae / Resume
  • Cover Letter
  • Optional Documents

  • List of References
  • Posting Supplemental Questions

    Required fields are indicated with an asterisk ().

  • Please select the response below that best describes your experience/education for the Social/Clinical Research Assistant position.
  • Bachelor's, Master's, and/or Doctorate in any field.
  • Associate's in any field and at least 2 years of experience.
  • Combination of post-high school education and experience to equal at least 4 years of related experience (ex: 1 year towards a degree and 3 years of experience).
  • High School diploma/GED and at least 4 years of related experience.
  • Did not complete high school but have a combination of high school education and experience to equal 8 years. (ex. 3 years of high school and 5 years of experience).
  • None of the above
  • Please describe your interest in clinical research.
  • (Open Ended Question)

  • What is the nature of your experience with maintaining regulatory documents?
  • (Open Ended Question)