Regulatory Associate

University of North Carolina- Chapel Hill

United States

August 2, 2021


Posting Information Position Type Permanent Staff (SHRA)

Is this an internal only recruitment? No Position Title Soc/Clin Research Specialist - Journey Working Title Regulatory Associate Position Number 20038061, 20038062 Vacancy ID P012522 Budgeted Hiring Range $53,772 - $60,000 Pay Band Information

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

Salary Grade Equivalent GN11 Full-time/Part-time Permanent/Time-Limited Full-Time Permanent If time-limited, estimated duration of appointment Hours per week 40 Work Schedule

Monday – Friday; 8:00 a.m. – 5:00 p.m.

Department Name and Number LCCC - Clinical Trials-426806 Date First Posted 03/26/2021 Closing Date 08/02/2021 Position Location Chapel Hill, NC Position Posting Category Research Professionals

Department Description

The UNC Lineberger Comprehensive Cancer Center, founded in 1975, is a National Cancer Institute (NCI)-designated comprehensive cancer center. The Center's mission is to reduce cancer occurrence and death in North Carolina and the nation through research, treatment, training and outreach.

UNC Lineberger's Clinical Protocol Office (CPO) is a centralized resource that supports the clinical research efforts of Lineberger investigators, primarily through the design and conduct of therapeutic clinical trials. The Protocol Office provides administrative, regulatory, data management, and study coordination services to investigators throughout the development, approval and implementation processes of protocols conducted at UNC and its affiliate institutions. The Protocol Office is responsible for protecting the safety of patients participating in research, ensuring the quality of the research, and safeguarding the interests of the University. It also furnishes protocol-related information to health professionals and to the community at large.

Equal Opportunity Employer

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.

Position Description


UNC Lineberger's Clinical Protocol Office (CPO) is recruiting for two Regulatory Associates. By applying to this recruitment you will be considered for both positions: 20038061 and 20038062.

The Regulatory Associate is responsible for regulatory compliance of an assigned disease group(s) which includes providing regulatory guidance and training to investigators and CPO staff; preparing and submitting required regulatory documents and responses to regulatory bodies (e.g., Institutional Review Boards (IRB)); and creating and maintaining professional working relationships with investigators, sponsors, team members, and others. These responsibilities relate to the UNC/LCCC CPO mission by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity.

Minimum Education and Experience Requirements

Bachelor's degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Essential Skills, Knowledge and Abilities

Demonstrated ability to provide consultation and lead exchange of research information through technical assistance and instruction. Demonstrated ability to train others, including documenting steps needed to collect information and to independently provide consultation to sites or others related to the specific protocols and regulatory guidance. Demonstrated ability to write comprehensive reports summarizing results and conveying to supervisory personnel. Demonstrated ability to plan work to meet objectives and deadlines.

Preferred Qualifications

Significant use of information technology is expected for this position. Experience in clinical research preferred, including familiarity with CFR Parts 50, 54, 56, 312, 314 and ICH Guidelines. CCRP, CCRC, CIRB or RAC Certification preferred. A cover letter is encouraged as an example of professional written communication skills. Master's degree or higher preferred. CCRP, CCRC, CIRB or RAC Certification preferred.

Required Licenses/Certifications Special Physical and Mental Requirements

Ability to lift/move 25 pounds and ability to move cart with files between 4-5 buildings with or without accommodation.

Position/Schedule Requirements Evening work occasionally, Weekend work occasionally Position Attributes Stimulus/ARRA Funded No 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.

Applicant Documents

Required Documents

  • Curriculum Vitae / Resume
  • Cover Letter
  • Optional Documents

    Posting Supplemental Questions

    Required fields are indicated with an asterisk ().

  • Have you received training in GCP and ICH Guidelines?
  • yes
  • no
  • Do you have experience submitting regulatory documents to regulatory bodies (e.g., Institutional Review Boards)?
  • yes
  • no
  • What are your interests in the field of clinical research?
  • (Open Ended Question)

  • Do you have experience drafting informed consent forms?
  • yes
  • no
  • Please describe your experience with multiple, concurrent projects.
  • (Open Ended Question)

  • Please select the response below that best describes your experience/education for the Social/Clinical Research Specialist position.
  • Bachelor's in a discipline related to the field assigned and at least 1 year of related training or experience.
  • Associate's, Bachelor's, Master's, Doctorate in an unrelated field and at least 5 years of related training and/or experience.
  • Master's and/or Doctorate in a discipline related to the field assigned.
  • Associate's in a discipline related to the field assigned and at least 3 years of related training or experience.
  • Combination of post-high school education and experience to equal at least 5 years of experience related to the field assigned (ex: 1 year towards a degree and 4 years experience).
  • Did not complete high school but have a combination of high school education and related experience to equal at least 9 years (ex. 3 years of high school and 6 years of experience).
  • None of the above
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