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
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
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
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
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
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.
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
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
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
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
5 years of experience in clinical research involving human subjects
Previous experience monitoring or auditing clinical research involving
SOCRA CCRP or ACRP CCRC/CCRA certification
Working knowledge of databases
Strong customer service skills
Special Physical and Mental Requirements
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 firstname.lastname@example.org
Please note: The Office of Human Resources will not be able to provide
specific updates regarding position or application status.
Curriculum Vitae / Resume
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)