Soc/Clin Research Specialist

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.

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 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 prepare tomorrow's healthcare professionals and biomedical researchers from all backgrounds by facilitating learning within innovative and integrated curricula and team-oriented interprofessional education to ensure a highly skilled workforce.

Research: We develop and support a rich array of outstanding health sciences research programs, centers and resources. We provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our university to support outstanding research. We foster programs in the areas of basic, translational, mechanistic and population research.

The Lead Clinical Data Management Associate will provide training and oversight to the Clinical Data Management Associates. The role will conduct study-specific planning and develop/test/validate electronic Case Report Forms, and implement clinical data management and data quality measures for clinical research studies at the UNC Lineberger Comprehensive Cancer Center. Primary duties include CDMA oversight, maintaining change control for clinical data management deliverables, develop Standard Operating Procedures, Work Instructions, and training materials. The Lead Clinical Data Management Associate will work with eCRF Developer and SDTM Programmer to maintain clinical data standards. The Lead Clinical Data Management Associate will act as a coach, mentor, and Subject Matter Expert within the department, aiding Management in process improvements, issue escalation, and training development and delivery. Support Lineberger Comprehensive Cancer Center in achieving objectives and strategic goals.

Relevant post-Baccalaureate degree required (or foreign degree equivalent); for candidates demonstrating comparable independent research productivity, will accept a relevant Bachelor's degree (or foreign degree equivalent) and 3 or more years of relevant experience in substitution. May require terminal degree and licensure.

Bachelor's degree (BS, BA) - 4 years clinical trials or data management experience

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. Demonstrated ability to implement data and information collection. Demonstrated ability to analyze data/information for accuracy, validity, and integrity; the ability to maintain quality control and assurance; the ability to apply criteria or parameters for extract of data/information; the ability to interpret and evaluate results; and the ability to prepare reports and/or presentations. Demonstrated ability to provide consultation and instruction.

Bachelor's degree (BS, BA) - 4 years of oncology clinical trials or data management experience
Master's Degree (MS, MA) - 2 years oncology clinical trials or data management experience

The University is an equal opportunity employer and welcomes all to apply without regard to age, color, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, or sexual orientation. We encourage all qualified applicants to apply, including protected veterans and individuals with disabilities.