Clinical Trials Quality Assurance Program Coordinator

University of North Carolina- Chapel Hill

United States

October 15, 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 Clinical Trials Quality Assurance Program Coordinator Position Number 20011986, 20038066 Vacancy ID P013423 Budgeted Hiring Range $53,700 - $68,000 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 GN11 Full-time/Part-time Permanent/Time-Limited Full-Time Permanent If time-limited, estimated duration of appointment Hours per week 40 Work Schedule

Monday – Friday, 8:00 AM – 4:30 PM

Department Name and Number Clinical Trials-621200 Date First Posted 09/01/2021 Closing Date 10/15/2021 Position Location Chapel Hill, NC Position Posting Category Research Professionals

Department Description

The core mission of the Office of Clinical Trials (OCT) is to ensure compliance with federal, state, and institutional requirements, supporting the Human Research Protection Program by conducting post IRB approval reviews of clinical studies, research billing reviews, monitoring ClinicalTrials.gov and conducting compliance checks prior to project account set up. This includes education, consultation, and guidance on the conduct of clinical trials.

The OCT serves as a central resource for UNC faculty, staff and departments involved in clinical trials research and for sponsors seeking to conduct clinical trials at UNC by:

  • Serving as the point of contact for questions or issues related to clinical trials
  • Provide assistance and consultation in budget development and preparation
  • Developing and providing education and training on the requirements and procedures related to the conduct of clinical research
  • Assisting researchers, staff, and departments with clinical trial project development
  • Serving as an expert resource for information on the issues and requirements for the conduct of clinical research
  • Developing and implementing programs and initiatives, based on monitoring and assessment, to enhance the quality of clinical research and to support regulatory compliance
  • Providing oversight and assisting with registration of clinical trial information and posting of results as appropriate in clinicaltrials.gov
  • 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 POSTING IS FOR TWO IDENTICAL POSITIONS (20011986, 20038066 ). BY APPLYING TO THIS POSTING, YOU WILL BE CONSIDERED FOR BOTH POSITIONS.

    The Clinical Trials Quality Assurance (CTQA) Program Coordinator will review/audit human subjects research for compliance with the terms and conditions of the IRB approval, sponsor or grant agreement, governing laws and regulations, Good Clinical Practice (GCP), and UNC-CH policies/procedures. The selected candidate will meet and discuss the reviews with the Principal Investigator (PI) and study team. A written report of the review will be provided to the PI/study team at the completion of the audit.

    The Office of Clinical Trials is currently testing a remote/hybrid work model as part of a larger University pilot program. This position is eligible for remote/hybrid work through December 31, 2021, with the possibility of extension.

    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

    The selected candidate must demonstrate the following:

  • Expert knowledge of US federal, state, and local regulations related to clinical research studies, including, but not limited to: 45CFR46, 21CFR312 and 812, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, GCP, University policies, and Office of Human Research Ethics standard operating procedures (SOPs)
  • Ability to interpret and understand research protocols for adherence to compliance
  • Proficiency with medical terminology and electronic health records
  • Excellent communication skills
  • Strong organizational skills and attention to detail
  • Strong time management and prioritization skills
  • Ability to critically analyze problems and provide solutions
  • Ability to conduct audits both on and off campus, including, but not limited to, hospital areas, clinics, community settings
  • Strong computer skills, including proficiency with Microsoft Office
  • Ability to work effectively both independently and as part of a team
  • Preferred Qualifications

  • 5 years of experience in clinical research involving human subjects
  • Previous experience monitoring or auditing clinical research involving human subjects
  • SOCRA CCRP or ACRP CCRC/CCRA certification
  • Working knowledge of databases
  • Strong customer service skills
  • Required Licenses/Certifications Special Physical and Mental Requirements Position/Schedule Requirements Position Attributes Stimulus/ARRA Funded No Quick Link https: // unc.peopleadmin.com/postings/198478

    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
  • 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
  • Please describe the skills and/or attributes you think are most important for someone interested in this position.
  • (Open Ended Question)

  • Please describe your experience with Microsoft Office 365 products (i.e., Teams, SharePoint, OneNote).
  • (Open Ended Question)

  • Describe your organizational techniques.
  • (Open Ended Question)