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Regulatory Coordinator

Job description

Position Type:

Permanent Staff (SHRA)

Is this an internal only recruitment?:

Position Title:

Soc/Clin Research Specialist - Journey

Working Title:

Regulatory Coordinator

Position Number:

20037803

Vacancy ID:

P012352

Budgeted Hiring Range:

$53,508 - $59,747

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 Time-Limited

If time-limited, estimated duration of appointment:

3 years

Hours per week:

Work Schedule:

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

Department Name and Number:

Globl Hlth and Infect Disease-427801

Date First Posted:

02/05/2021

Closing Date:

03/04/2021

Position Location:

Chapel Hill, NC

Position Posting Category:

Research Professionals

Department Description:

The Division of Infectious Diseases conducts investigator-initiated, industry-funded, NIH funded AIDS prevention and treatment, sexually transmitted infections, other infectious diseases scientific and clinical research, and provides patient care at UNC-Chapel Hill and at sites throughout the world. The University of North Carolina is dedicated to developing and conducting research on HIV prevention, HIV infection as well as conducting research in other infectious diseases.

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 primary purpose of this position will be to prepare submissions to IRB and other regulatory bodies including external IRBs, FDA and NIH and communicate with staff, sponsors, and monitors regarding regulatory issues for clinical trial protocols, including multicenter and IND studies. This person will work within the regulatory department of the Institute for Global Health and Infectious Diseases on
ongoing clinical research studies. Main responsibilities include:

- Perform independent and dependable work in preparation and coordination of study submissions to IRB (UNC ethics board) and other appropriate committees following regular deadlines;
- Communicate with study staff, IRB, sponsors, domestic and international study partners in a courteous and professional manner;
- Meet with study sponsor representatives as needed;
- Prepare informed consent forms that follow appropriate regulations and meet sponsor requirements;
- Address queries and memos from IRB and other regulatory authorities, prepare clinicaltrial.gov submission;
- Maintain and organize electronic and paper regulatory documents and study files;
- Perform Quality Assurance/Quality Control of study files;
- Track and enter regulatory submissions using an electronic database, prepare reports using a database;
- Participate in guideline development as appropriate, streamline processes;
- Aid in training of study staff on regulatory procedures and compliance issues, adverse events, and protocol deviations;
- Communicate potential issues to regulatory supervisor, study team members, investigators;
- Assist other staff members in completion of work in a team-oriented fashion;
- Complete other regulatory duties as assigned.

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:

This person must be detail-oriented and conscientious and be comfortable communicating with a diverse audience.

Preferred Qualifications:

- Advanced degree in science
- Experience working in clinical research

Position/Schedule Requirements:

Evening work occasionally, Overtime occasionally, Weekend work occasionally

Stimulus/ARRA Funded: