Clinical Research Quality Assurance Manager

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 - 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 Work Schedule

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

Department Description

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 management.

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

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 institutions.

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 contract • 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 writing • 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.

Preferred Qualifications

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.

Required Licenses/Certifications Special Physical and Mental Requirements Position/Schedule Requirements Position Attributes Stimulus/ARRA Funded No Quick Link https: // unc.peopleadmin.com/postings/198976

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

  • 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)?
  • Yes
  • No
  • Describe your advanced knowledge of clinical research coordination.
  • (Open Ended Question)