Clinical Research Coordinator II

University of North Carolina- Chapel Hill

United States

August 6, 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 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 Work Schedule

Monday-Friday 8:00 a.m.- 5:00 p.m. Hours may vary based on the needs of projects assigned.

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

Department Description

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.

Position Description

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 quality assurance.

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 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.

Preferred Qualifications

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.

Required Licenses/Certifications Special Physical and Mental Requirements Position/Schedule Requirements Exposure to Bloodborne Pathogens Position Attributes 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 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
  • List of References
  • Optional Documents

    Posting Supplemental Questions

    Required fields are indicated with an asterisk ().

  • Do you have knowledge of ICH-GCP, Federal Regulations and Guidelines?
  • yes
  • no
  • Do you have experience in drug/device clinical trial coordination? 
  • Yes
  • No
  • How many years of Gastroenterology clinical trial coordination do you have?
  • None
  • Less Than One Year
  • 1-2 Years
  • 3+ Years
  • 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
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