Clinical Data Management Associate

UNC-Chapel Hill • Chapel Hill, NC

5d

About The Position

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.

Requirements

• Knowledge of clinical trial design
• Knowledge of 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
• Knowledge of 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
• the ability to prepare reports and/or presentations
• Demonstrated ability to provide consultation and instruction

Nice To Haves

• Master’s degree preferred.

Responsibilities

• developing and maintaining Data Management Plans
• developing and maintaining Data Validation Plans
• developing and maintaining Form Completion Guidelines
• 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
• training of study teams in study data management

What This Job Offers

• Career Level: Entry Level
• Education Level: No Education Listed