The primary purpose of this position is to act as a clinical research team lead within the CGIBD. This includes managing the day to day operations of study activities of the assigned research pod, consisting of managing 2 to 6 clinical research coordinators locally. Team leads are also responsible for managing small scale investigator initiated projects which may include protocol writing, case report form design, database creation, and reporting to funding agencies. The team lead is also responsible for independently coordinating the most complex clinical 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, this position will primarily function as a team lead within CEDAS, managing assigned coordinators and ensuring coordinators are adequately trained and compliant with all applicable federal regulations, local regulations, good clinical practices, and protection of human subjects. The team lead is also responsible for advanced complex trial coordinator (for example, implanted investigational device projects), and managing 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.), performing contracted services for sponsors, and contract and budget development and negotiations for upcoming trials. The team lead may also perform interim interpretation and analyses of data for studies within the team throughout the study to make certain they stay on the projected track utilizing various systems/data analysis programs (Excel, Access, STATA, SAS, SPSS). The team lead 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, and travel.
Education and Experience:
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.
The candidate must have advanced knowledge on how to coordinate investigational drug and device clinical trials.
Candidates must possess strong decision-making skills and the ability to problem solve and troubleshoot issues.
Candidates must have proven leadership skills and ability to educate, supervise, and lead other coordinators. Ability to identify and address performance issues with assigned staff and make decisions about study assignments and work load of supervised employees. Ability to project group needs and effort required for assigned projects.
Extensive clinical research regulatory knowledge required, including mastery and understanding good clinical practice (ICH/GCP), FDA code of federal regulations, and regulations and policies related to human subjects research. In addition to this extensive knowledge, candidates must be able to apply this knowledge to the workplace and is responsible for ensuring supervised staff understand and follow these regulations. This may require holding educational meetings and training with staff on topics identified as requiring additional training.
High level of accuracy and attention to detail are required for this position.
Candidates must have the ability to interpret protocols and identify potential logistical and scientific issues in protocol design.
Candidates must have the ability to actively participate in protocol development and writing manuals of operation and case report forms for data collection as well as database design and building.
Candidates must have the ability to contribute to preparation of publications, reports, and other presentations of compiled study results.
Candidates must have excellent skills in computer usage especially Microsoft Word, Excel, Access, PowerPoint, remote data entry, and database management.
Candidates must have strong project management skills, including independently creating methods to track and manage study progress as well as monitoring progress of trials coordinated by supervised employees.
Prefer at least 2 years of experience coordinating investigational drug and/or device trials in GI at UNC.
Prefer experience using investigational drug services. Prefer experience working with the food and drug administration (FDA).
Prefer experience understanding clinical trial billing compliance rules per NCD310.1.
Prefer candidates with knowledge of UNC regulations and policies related to human subjects research.
Prefer candidates with at least 1 year of experience in gastrointestinal clinical trial coordination involving investigational drugs or devices.
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.
Internal Number: 155276
About The University of North Carolina at Chapel Hill
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