Position Type Permanent Staff (SHRA)
Is this an internal only recruitment? No
Position Title Soc/Clin Research Specialist - Journey
Working Title Regulatory Coordinator
Position Number 20037441
Vacancy ID P012927
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 40
Monday – Friday 8am – 5pm
Department Name and Number Globl Hlth and Infect Disease-427801
Date First Posted 06/18/2021
Closing Date 09/17/2021
Position Location Chapel Hill, NC
Position Posting Category Research Professionals
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.
THIS IS A TIME LIMITED POSITION WITH AN ESTIMATED DURATION OF 3 YEARS.
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 ongoing clinical research studies. Main responsibilities
- 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
- Address queries and memos from IRB and other regulatory authorities,
prepare clinicaltrial.gov submission;
- Maintain and organize electronic and paper regulatory documents and study
- 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,
- Assist other staff members in completion of work in a team-oriented
- 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
Essential Skills, Knowledge and Abilities
This person must be detail-oriented and conscientious and be comfortable
communicating with a diverse audience.
Advanced degree in science
Experience working in clinical research
Special Physical and Mental Requirements
Position/Schedule Requirements Evening work occasionally, Overtime
Stimulus/ARRA Funded No
Quick Link https: // unc.peopleadmin.com/postings/194489
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 email@example.com
Please note: The Office of Human Resources will not be able to provide
specific updates regarding position or application status.
Curriculum Vitae / Resume
List of References
Posting Supplemental Questions
Required fields are indicated with an asterisk ().
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
Do you have clinical research experience?
Do you have prior IRB experience?
Are you detail oriented and conscientious, and comfortable communicating with a diverse audience?