Regulatory Documents Specialist
Permanent Staff (SHRA)Is this an internal only recruitment?:
Soc/Clin Research Assistant - JourneyWorking Title:
Regulatory Documents SpecialistPosition Number:
P012093Budgeted Hiring Range:
$40,944 - $47,768Pay 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 PermanentHours per week:
Monday – Friday, 8am-5pmDepartment Name and Number:
Globl Hlth and Infect Disease-427801Date First Posted:
Chapel Hill, NCPosition Posting Category:
Research ProfessionalsDepartment 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:
THIS IS A REPOST. PREVIOUS APPLICANTS ARE STILL BEING CONSIDERED AND NEED NOT REAPPLY.
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 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:
Applicant should be knowledgeable about clinical research, IRBs, and regulatory affairs. Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.Preferred Qualifications:
Applicant should be able to work in a fast-paced environment and to alternate between studies and various tasks as needed.
Applicant 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 occasionallyStimulus/ARRA Funded: