Permanent Staff (SHRA)Is this an internal only recruitment?:
Soc/Clin Research Specialist - ContributingWorking Title:
Study CoordinatorPosition Number:
P012360Budgeted Hiring Range:
$45,000 - $55,000Pay Band Information:
To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.Salary Grade Equivalent:
Full-Time PermanentHours per week:
8am – 5pm Monday – FridayDepartment Name and Number:
Medicine - Cardiology-411405Date First Posted:
Chapel Hill, NCPosition Posting Category:
Research ProfessionalsDepartment 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.
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.Position/Schedule Requirements:
Overtime occasionally, Patient care involved, Weekend work occasionallyStimulus/ARRA Funded: