"Soc/Clin Research Specialist"

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.

Education and Experience: 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.

Essential Skills: 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.