Clinical Data Management Associate

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 Clinical Data Management Associate conducts clinical data management activities on oncology clinical research data collected for investigator-initiated trials sponsored by the UNC Lineberger Comprehensive Cancer Center. The primary duties involve quality oversight of multiple clinical trials, including developing and maintaining Data Management Plans, Data Validation Plans, Form Completion Guidelines, and other instructions; conducting study-specific testing and validation of electronic Case Report Forms; comprehensive quality oversight of data collection; extraction of data and reporting; consultation with investigators; and training of study teams in study data management.

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.

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.

Master's degree preferred.