Regulatory Assistant

Job description

Position Type:

Permanent Staff (SHRA)

Is this an internal only recruitment?:


Position Title:

Soc/Clin Research Assistant - Journey

Working Title:

Regulatory Assistant

Position Number:

20005702, 20038059, 20038060

Vacancy ID:


Budgeted Hiring Range:

$40,945 - $45,500

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:


Full-time/Part-time Permanent/Time-Limited:

Full-Time Permanent

Hours per week:


Work Schedule:

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

Department Name and Number:

LCCC - Clinical Trials-426806

Date First Posted:


Closing Date:


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 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 three Regulatory Assistants. By applying to this recruitment you will be considered for all three positions: 20005702, 20038059 and 20038060.

The primary purpose of this position is to provide para-professional support within the Regulatory staff of the Lineberger 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. Regulatory Assistants participate in the collection, compilation and management of data/information; quality assurance and quality control; analysis by statistical or other means; generation/production of new data/information; and editing and formatting of reports. Regulatory Assistants are expected to use considerable judgment and 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.

Essential Skills, Knowledge and Abilities:

Working knowledge of 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 and the ability to communicate professionally both verbally and in writing.

Preferred Qualifications:

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

Special Physical and Mental Requirements:

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

Position/Schedule Requirements:

Evening work occasionally, Overtime occasionally, Weekend work occasionally

Stimulus/ARRA Funded:





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Job No:
Posted: 6/2/2021
Application Due: 6/12/2021
Work Type: Full Time