Flexible work arrangements, including virtual/hybrid work locations, are an integral part of the School of Medicine's Working Forward initiative. As such, this position's work location is designated as hybrid. Please note that the designated work location is subject to change based on the unit's business needs.
The Dr. Joseph Muenzer MPS Research & Treatment Center (Muenzer MPS Center) is focused on improving the outcomes of individuals with mucopolysaccharidosis (MPS) and their families and developing new treatments. The Muenzer MPS Center team is dedicated to developing new avenues of treatment for children and adults with MPS, a group of ultra rare genetic disorders, including clinical trials to test new forms of intravenous enzyme replacement therapy as well as alternative therapies, such as gene therapy and intrathecal drug delivery devices.
The Muenzer MPS Center (Director Dr. Joseph Muenzer) offers an exciting opportunity for a Clinical Research Specialist to become an integral part of this fast growing and successful team. You will work directly with the PIs (Dr. Joseph Muenzer and Dr. Elizabeth Jalazo) and with the MPS Research Clinical Director (Lindsay Torrice, CPNP) on our clinical trials delivering novel therapeutics to children/adults with MPS and other lysosomal storage disorders. This is a highly rewarding job working with our interdisciplinary and highly collaborative team of physicians, advanced practice providers, research staff, and dedicated health professionals, who love working with children and adults with rare genetic disorders and are dedicated to improving their health and quality of life. This position also offers flexibility with a combination of in-person (at our clinic in Chapel Hill, NC) and remote (at-home) work.
The Clinical Research Specialist will support our research team with primary responsibility for study startup activities, including interacting with study sponsor, study monitor (CRO), Principal/Sub-Investigators and other UNC entities and departments as appropriate (e.g., Clinical Translational Research Center, Investigational Drug Services, Radiation Safety committee). The Specialist will be responsible for ensuring timely submissions of start-up documents to the sponsor/CRO, including financial disclosures, CVs, and training certifications. The Specialist will have primary responsibility for developing and revising study budgets with oversight from Principal/Sub-Investigator (PI/Sub-I). The Specialist will be responsible for creating source documents per study protocol and process manuals. The Specialist will be responsible for study closeout activities, including working with CRO to ensure completeness and accuracy of records during closeout, and working with billing coordinator to ensure all budget items are resolved.
The Specialist will participate in ongoing clinical trials including ensuring adherence to updated protocols, interacting with study sponsor and study monitor to ensure completion and documentation of study-related procedures and events. The study coordinator may assist in preparation of study source documents, data entry into the appropriate EDC (electronic data capture) and response to data queries from study monitor(s). Additional duties may be assigned depending on team/study needs.
The candidate should be able to manage multiple competing priorities and to make important decisions while adhering to study protocols and data quality. The candidate should be willing to take initiative in new and current projects. The candidate should be able to work independently and to collaborate with other members of the research team.
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.
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.