Study Coordinator

University of North Carolina- Chapel Hill

United States

June 18, 2021

Description

Posting Information Position Type Permanent Staff (SHRA)

Is this an internal only recruitment? No Position Title Soc/Clin Research Specialist - Contributing Working Title Study Coordinator Position Number 20018590 Vacancy ID P012360 Budgeted Hiring Range $45,000 - $55,000 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

8am – 5pm Monday – Friday

Department Name and Number Medicine - Cardiology-411405 Date First Posted 02/09/2021 Closing Date 06/18/2021 Position Location Chapel Hill, NC Position Posting Category Research Professionals

Department Description

The Division of Cardiology is within the Department of Medicine. The clinical trials groups within Cardiology bridges the realm of bench science with that of daily clinical care rendered to patients within our healthcare system. Through clinical trials, its principal investigators and trials staff provide the mechanism for the collection of data to determine the efficacy and safety of new pharmaceuticals and devices. Trial recruitment and management is critical to the success of the program, and relies heavily on the independent work of study coordinators. Ethical considerations must be paramount as our first priority is patient safety- therefore there are significant regulatory requirements (internal to the university, as well as to numerous external agencies). There are two distinct groups managing clinical trials within Cardiology – heart failure and general cardiology. In addition, several faculty members' work on investigator initiated research, employing clinical and administrative staff, interns, and work study students to assist. The general cardiology clinical trials group manages a complex array of industry, federal (NIH), and investigator-initiated trials.

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

THIS IS A REPOST. PREVIOUS APPLICANTS ARE STILL BEING CONSIDERED AND NEED NOT REAPPLY.

The primary duties of the Study Coordinator are coordinating and processing the administrative and regulatory paperwork associated with ongoing and new Cardiology clinical research trials. Duties include (but are not limited to): recruiting and consenting patients, attending off-site study meetings as required, scheduling and completing subject follow-up visits, sample processing, attending study teleconferences/training, facilitating investigator and trials personnel training, performing data abstraction and completion of CRFs, adverse event/outcome monitoring and reporting, maintenance of subject research charts, and facilitating study monitor visits. Additionally, the study coordinator will track subject visits and site payments, prepare and submit site invoices, utilize complex tracking and budgeting tools to enable accurate forecasting and reconciliation of site and subject payments. The study coordinator prepares all documents required for IRB initial and continuing review (IRB application, consent & HIPPA forms) and prepares and submits regulatory documents as required by trial sponsor.

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

A basic knowledge of social/clinical research principles, ICH/GCP guidelines, study design, methods of data/information collection and analysis used to complete defined assignments is required. The ability to multi-task while maintaining accuracy is essential. Ability to write detailed regulatory documents. Ability to communicate verbally and in writing with patients with diverse educational levels – simple, concise, empathetic communication. Excellent written and verbal communications skills are needed in order to build collaborative relationships with hospitals, clinics, physicians, patients, and coordinating centers/sponsors. Ability to work collaborative in a team, and independently.

Preferred Qualifications

Strong preference for candidates with experience in clinical research, specifically experience working with IRB/regulatory agencies, application of ICH/GCP guidelines, and experience in cardiology. Previous experience with clinical trial billing preferred. Prefer candidates with a working knowledge of Microsoft Office products – specifically Microsoft Word and Microsoft Excel. Prior experience using Excel highly preferred. The preferred candidate will be able to work both collaboratively in a team and independently. A high level of organizational skills, specifically with electronic and paper files is preferred. Knowledge of medical terminology highly preferred. Prior exposure to cardiovascular health highly preferred. Clinical trial certification a plus.

Required Licenses/Certifications Special Physical and Mental Requirements Position/Schedule Requirements Overtime occasionally, Patient care involved, Weekend work occasionally Position Attributes Stimulus/ARRA Funded No Quick Link https: // unc.peopleadmin.com/postings/188307

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 ().

  • Please describe your experience with clinical trials (specifically, indicate any clinical cardiovascular disease research experience you may have).
  • (Open Ended Question)

  • What is your level of proficiency in Excel?
  • Expert
  • Intermediate
  • Beginner
  • Do you have experience with clinical trial billing and/or invoicing?
  • yes
  • no
  • Do you currently have any of the following nationally recognized clinical trial certifications: CCRP, CCRC, CCRA, or ACRP-CP
  • Yes
  • No
  • 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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