Regulatory Coordinator

University of North Carolina- Chapel Hill

United States

September 17, 2021

Description

Posting Information 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 Work Schedule

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

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 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 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

Required Licenses/Certifications Special Physical and Mental Requirements Position/Schedule Requirements Evening work occasionally, Overtime occasionally Position Attributes 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 employment@unc.edu

Please note: The Office of Human Resources will not be able to provide specific updates regarding position or application status.

Applicant Documents

Required Documents

  • Curriculum Vitae / Resume
  • Cover Letter
  • List of References
  • Optional Documents

    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?
  • Yes
  • No
  • Do you have prior IRB experience?
  • Yes
  • No
  • Are you detail oriented and conscientious, and comfortable communicating with a diverse audience?
  • Yes
  • No
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