Regulatory Documents Specialist

Job description

Position Type:

Permanent Staff (SHRA)

Is this an internal only recruitment?:


Position Title:

Soc/Clin Research Assistant - Journey

Working Title:

Regulatory Documents Specialist

Position Number:


Vacancy ID:


Budgeted Hiring Range:

$40,944 - $43,000

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:


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

Full-Time Permanent

Hours per week:


Work Schedule:

Monday – Friday; 8am-5pm
(Hours vary based on project needs)

Department Name and Number:

Globl Hlth and Infect Disease-427801

Date First Posted:


Closing Date:


Position Location:

Chapel Hill, NC

Position Posting Category:

Research Professionals

Department Description:

The UNC Institute for Global Health and Infectious Disease (IGHID) is a multi-departmental center within the School of Medicine which exists to conduct infectious disease scientific, clinical, epidemiological, and behavioral research domestically and internationally, as well as provide technical assistance for the developing of HIV care and prevention programs.

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:

The Regulatory Documents Specialist will work within the regulatory department of the Institute for Global Health and Infectious Diseases on clinical research and epidemiological studies. The primary purpose of this position will be to maintain and organize regulatory documents, study files and training records, communicate with study staff, IRB, sponsors, study partners, arrange meetings between all parties and take minutes, arrange monitoring visits and assist monitors, assist and create submissions for IRB, perform quality control and quality assurance of consent forms, assist in the creation of SOPs and work instructions, create reports of study information, perform other administrative tasks as assigned by supervisor.

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:

Applicants should be knowledgeable about clinical research, IRBs, and regulatory affairs. Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.

Preferred Qualifications:

Applicants should be able to work in a fast-paced environment and to alternate between studies and various tasks as needed.

Applicants should be detail-oriented and conscientious.

Should also be comfortable communicating with study staff, investigators, IRB, study sponsors, domestic and international study partners, audit staff, including FDA.

Position/Schedule Requirements:

Evening work occasionally, Overtime occasionally

Stimulus/ARRA Funded:





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Job No:
Posted: 2/25/2021
Application Due: 3/6/2021
Work Type: Full Time