Position Type Permanent Staff (SHRA)
Is this an internal only recruitment? No
Position Title Soc/Clin Research Specialist - Advanced
Working Title Clinical Research Quality Assurance Manager
Position Number 20039346
Vacancy ID P013473
Budgeted Hiring Range $60,000- $67,000
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 GN14
Full-time/Part-time Permanent/Time-Limited Full-Time Time-Limited
If time-limited, estimated duration of appointment 2 years
Hours per week 40
Monday-Friday; 8:00am- 5:00pm
Department Name and Number Neurology-411801
Date First Posted 09/09/2021
Closing Date 09/17/2021
Position Location Chapel Hill, NC
Position Posting Category Research Professionals
In the past decade, neurologists have made great advances in the treatment of
such devastating neurological disorders as stroke, multiple sclerosis,
Alzheimer's disease, and Parkinson's disease. Aided by modern techniques of
neuro-imaging, genetics, biochemistry, pharmacology and clinical trial
methodology, neurology has emerged from its origins as primarily a diagnostic
specialty into a new era of therapeutic successes. The Department of Neurology
at the University of North Carolina Chapel Hill is in the forefront of this
new era as a leader in teaching, providing, and discovering new treatments for
neurological diseases while caring for patients in North Carolina.
The department boasts over 50 faculty with broad subspecialty representation
in epilepsy, sleep disorders, movement disorders, neuromuscular diseases,
cerebrovascular diseases, pediatric neurological disorders, multiple
sclerosis, neuroimmunology, behavioral neurology, cognitive and memory
disorders, neurogenetics, neuro-oncology, and neurocritical care.
The Neurosciences Clinical Trials Unit (NCTU) supports over 60 active
industry, Federal funded, and investigator-initiated studies at any given
time. Current trials include those for epilepsy, memory, and cognitive
disorders, neurocritical care, neuromuscular disorders, stroke, movement
disorders, multiple sclerosis, pediatric neurology, and neurosurgical spine.
The NCTU model strengthens research support by providing highly-trained
research coordinators who collaborate with investigators and sponsors with the
goal of conducting clinical trials efficiently and with the highest standards.
The NCTU team provides our experienced investigators with primary
coordinators, back-up coordinators, and administrative support to assist with
regulatory compliance, budgets, and finance oversight, as well as quality
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.
NCTU Research Quality Assurance Officer, serves in a leadership position
within the NCTU.
This position manages, conducts, and evaluates the social/clinical research
associated with the Department of Neurology. The work performed is to support
research programs and policies. This position validates data/information
collection, documentation, and analysis with a goal of performing good
clinical practice. The range of duties include, but not limited to: project
planning and design, project budget assessment, data/information collection
and analysis, project administration, program and/or policy development and
evaluation (develop and maintain Quality Evaluation SOPs), and preparing
reports. Work will also include the managing of the NCTU research quality
improvement and assurance program. Maintaining accuracy and quality throughout
a clinical study is a continual, dynamic process. Study requirements are
carefully set forth initially however, project expectations and requirements
often change during a study. This ongoing process requires revising
mechanisms, communicating, and educating about new expectations and revisions.
Quality evaluations/audits are designed to provide assurance that the data
reported on research accurately reflects data collected and compliance with
protocol and regulatory requirements. This position will assist the NCTU
Director provide a systematic and independent examination of all trial related
activities and documents. The position will survey studies for regulatory and
data management practices and compliance while providing support and education
to staff and faculty. The audits will determine whether the evaluated
activities were appropriately conducted, and that the data were generated,
recorded, analyzed, and accurately reported according to protocol, standard
operating procedures (SOPs), and good clinical practices (GCPs).
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 must be able to:
• Demonstrate a strong working knowledge of research, regulatory compliance
(FDA, ICH, GCP) and ability to understand a clinical protocol and research
• Experience in research coordination or management • Hold a clinical research
certification (CCRP, CCRC, ACRP-CP, RAC)
• Experience in creating administrative tools, developing, and implementing
new processes, and drafting standard operating procedures
• Experience in performing quality audits for compliance
• Experience in educating research coordinators
• Communicate effectively, efficiently, and diplomatically, both orally and in
• Work independently and able to multitask in a fast-paced environment,
prioritize high-volume work-load with minimal supervision
• Critical thinking skills for problem solving with strategic thinking
capacity to drive the research studies while understanding the upstream and
downstream implications of decisions that affect study timelines.
• Plan work to meet established deadlines
• Adaptable/flexible, independent critical thinker, able to adjust to
challenges with confidence and professionalism.
Strong background in clinical research with understanding of clinical trial
management and ability to understand a clinical protocol, schedule of
activities and research contract. Strong background in creating research
educational programs and performing quality compliance audits. Minimum of 8
years-experience in research coordination or management.
Special Physical and Mental Requirements
Stimulus/ARRA Funded No
Quick Link https: // unc.peopleadmin.com/postings/198976
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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 familiarity with appropriate regulatory guidelines (ICH, FDA, CFR, GCP)?
Describe your advanced knowledge of clinical research coordination.
(Open Ended Question)