Position Type Permanent Staff (SHRA)
Is this an internal only recruitment? No
Position Title Soc/Clin Research Specialist - Journey
Working Title Clinical Research Coordinator II
Position Number 20019584
Vacancy ID P013104
Budgeted Hiring Range $47,500 - $53,000
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 a.m.- 5:00 p.m. Hours may vary based on the needs of
Department Name and Number Gastroint Biology and Dis Ctr-429001
Date First Posted 07/20/2021
Closing Date 08/06/2021
Position Location Chapel Hill, NC
Position Posting Category Research Professionals
The Center for Gastrointestinal Biology and Disease (CGIBD) promotes
research and teaching on all aspects of gastrointestinal biology, physiology,
and epidemiology. The Center for Esophageal Diseases and Swallowing (CEDAS)
is within the CGIBD with special emphasis on esophageal diseases. The goals of
CEDAS are to:
1. Collaborate with investigators and clinicians at the University of North
Carolina at Chapel Hill (UNC-CH), North Carolina State University (NCSU),
and other Universities with interest in esophageal and swallowing diseases.
2. Facilitate collaborative research, clinical care, and educational projects
among center members.
3. Serve as a focus tor the solicitation of outside funds from private,
foundation, industrial, and governmental sources.
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.
The primary purpose of this position is to serve as an advanced clinical
research coordinator within the CGIBD. This includes independently
coordinating the most complex investigational drug and device trials within
their assigned unit.
Employing extensive clinical research regulatory knowledge, including mastery
and understanding of good clinical practice (ICH/GCP), FDA code of federal
regulations, and UNC regulations/ policies related to human subjects research,
the CRC II is responsible for advanced complex trial coordination (for
example, implanted investigational device projects, infusion drug studies,
etc.), and assisting with advanced tasks including advanced regulatory
management (such as the scientific writing of an investigator's brochure
summarizing research findings to date, submissions to the FDA, etc.), and
performing contracted services for sponsors. The CRC II may also manage small
scale multi-site projects from the ground-up including writing investigational
clinical trial research protocols, detailing study procedures, hypothesis, and
aims, case report form design, database design, multi-site data and regulatory
management; as well as assist research managers with staff training and
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 candidate should have excellent verbal and written communication skills
with ability to interact with clinical investigators, laboratory personnel,
study sponsors, IRB, Office of Clinical Trials, and support staff. Working
knowledge of medical terminology, techniques and methodologies used in
developing, coordinating and managing clinical research projects. Applicant
must have a working knowledge of FDA Code of Federal Regulations (CFR) and
International Conference on Harmonisation Good Clinical Practice (ICH GCP)
as well as familiarity with local, state and federal guidelines governing
clinical trials. The candidate must be experienced in initiating, maintaining
and updating protocols with central and local IRBs and minting the appropriate
regulatory documents. Applicant should have a working knowledge of database
management and spreadsheets. Ability to learn quickly, work independently and
efficiently with minimal supervision, prioritize tasks, and work under
deadline pressure. Flexibility is required for intermittent evening and
weekend hours as needed for patient enrollment after normal business hours.
Experience with clinical research (including the UNC IRB processes, FDA
regulatory requirements, ICH GCP guidelines, ACRP or SOCRA certification) is
strongly desired. Gastrointestinal clinical trial experience and familiarity
with both NIH and industry-sponsored research studies preferred. Management
and leadership experience is highly desired.
Special Physical and Mental Requirements
Position/Schedule Requirements Exposure to Bloodborne Pathogens
Stimulus/ARRA Funded No
Quick Link https: // unc.peopleadmin.com/postings/195928
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
List of References
Posting Supplemental Questions
Required fields are indicated with an asterisk ().
Do you have knowledge of ICH-GCP, Federal Regulations and Guidelines?
Do you have experience in drug/device clinical trial coordination?
How many years of Gastroenterology clinical trial coordination do you have?
Less Than One Year
Describe your ability to manage multiple projects with competing deadlines.
(Open Ended Question)
Describe your organizational techniques.
(Open Ended Question)
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