DSM Coordinator

M-F 8:00 am- 5:00 pm; flexible.

Flexible work arrangements, including remote/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.

To learn more about the pay band for this branch and role, please see the Career Banding rates spreadsheet.

A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn.

One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community.

University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance.

The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing of North Carolinians, and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research. We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability. We optimize our partnership with the UNC Health System through close collaboration and commitment to service.
OUR VISION
Our vision is to be the nation's leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding.
OUR MISSION
Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education, and research.
Patient Care: We will promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond.
Education: We will prepare tomorrow's health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce.
Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research.

This position provides support for the critical functions of the Data and Safety Monitoring Committee ( DSMC) for the Lineberger Clinical Protocol Office. As an NCI designated Cancer Center, LCCC is expected to convene a DSMC for safety review and quality oversight of clinical trials conducted at LCCC. The DSMC Coordinator will extract study enrollment details, safety reports, protocol deviations and other information from the oncology databases (e.g., OnCore) for DSMC review. The coordinator runs the internal DSMC meeting every 2 weeks and the DSMC Blue monthly meeting comprised of external reviewers from other academic sites.

Additional duties include participation in process improvement initiatives, including recommending and implementing changes to processes as needed, assisting with the monitoring of cooperative group charts and facilitating monitoring reports (including design of systems to organize and distribute queries to relevant staff), follow-up to ensure compliance, and training staff to appropriately. This position is a member of the Compliance Committee.

Bachelor's degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions.

Excellent communication and organizational skills
Knowledge of Code of Federal Regulations and Good Clinical Practice Parts 50, 54, 56, 312, 314.
Knowledge of clinical research principles as defined by Code of Knowledge of clinical trial design; clinical research principles as defined by Code of Federal Regulations including Good Clinical Practices ( GCP) 21 CFR Parts 50, 54, 56, 312, 314 along with ICH Guidelines and Health Insurance Portability and Accountability Act ( HIPAA) regulations pertinent to research; clinical trials management and electronic data capture systems such as OnCore.
Demonstrated ability to collect data and provide reports using information technology systems, compiled data, and reported outcomes.
Demonstrated ability to establish goals, objectives, and excellent management of timelines
Demonstrated ability to review data for accuracy, and provide meaningful feedback to address discrepancies, suggested corrective actions and training needs
Demonstrated ability to provide and organize reports and data, advanced writing and editing skills, and strong attention to detail
Demonstrated ability to facilitate development of complete processes and procedures

Certification, such as RN, MT, PA, RPh, RT, or QARC
Experience in clinical research
Experience in Quality Assurance

Not Applicable.

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.

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.