The primary purpose of this position is to serve as a clinical research specialist for the CGIBD with a primary focus of expanding CGIBD research projects to UNC Health network entity locations in Raleigh (Rex) and recruiting for CGIBD research projects at these locations. This position will build relationships to pave the way for expansion of human subjects research projects at Rex ensuring compliance with both UNC-Chapel Hill and UNC Health research policies. The position will work with investigators at both UNC Chapel Hill and Rex. They will directly interact with Rex patients and recruit them into clinical research studies in compliance with protocols, IRB, and good clinical practices, conducting all study procedures per protocol. While there will be investigators on-site to assist as necessary, they will be directly supervised by staff based at the UNC Chapel Hill campus and must be able to work independently with minimal to no direct supervision on a day to day basis. Excellent communication skills are essential, as well as strong independent decision-making and attention to detail. Candidates must have extensive clinical research regulatory knowledge and experience with IRB, including mastery and understanding of good clinical practice (ICH/GCP), FDA code of federal regulations, and UNC regulations/policies related to human subjects research. Duties include but are not limited to IRB submissions and maintaining IRB approval; screening, identifying, consenting, and enrolling patients into clinical research studies; collecting and entering data; collecting and processing biological specimens (urine, blood, stool, biopsies, saliva, etc.); essential document collection and maintenance, ensuring staff are trained on study procedures; and all activities are in compliance with applicable regulations and policies.
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.
Candidates must have advanced knowledge of clinical trial coordination. Candidates must possess strong decision-making skills and the ability to problem solve and troubleshoot issues. Candidates must have exceptional interpersonal skills. Extensive clinical research regulatory knowledge required, including mastery and understanding of good clinical practice (ICH/GCP) and FDA code of federal regulations. Candidates must be able to apply regulatory requirements to the workplace and are responsible for ensuring staff understand and follow these regulations. This may require holding educational meetings and trainings 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 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. Candidates must be willing and able to travel between Raleigh and Chapel Hill as needed to fulfill position duties.
Prefer at least 2 years of experience coordinating research studies at UNC. Prefer extensive understanding and experience with UNC regulations and policies related to human subjects research.
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.
Carolina rates among the nation’s great institutions of higher education, set on an historic and beautiful campus that celebrates all four seasons. Carolina’s students, faculty and staff come here from around the world, bringing varied cultural, racial and ethnic heritages that help make UNC-Chapel Hill a thriving intellectual center. We’re repeatedly ranked the nation’s best value in higher education for students seeking to earn a college degree – the University has garnered the top spot each time since the ranking’s launch in 1998.Whether you’ve just started your career, are new to academia or are a seasoned professional with assorted campus experiences to draw on, we hope you will find a great place at Carolina.