Clinical Data Coordinator
Posting ID: JP-002659783
Contract Clinical Data Coordinator/Management Associate Position Description
The Clinical Data Management Associate will implement clinical data management and data quality measures for clinical research studies at the UNC Lineberger Comprehensive Cancer Center. The primary duties involve study-specific planning and design of data collection; design, development, testing and validation of electronic Case Report Forms; comprehensive quality oversight of data collection and analysis; consultation with investigators; and training of study teams in study data management. Clinical Data Management Associates (CDMAs) typically manage 20 trials with combined accrual of 500, some in activation, some actively recruiting, some in follow up, some closed – working on manuscripts and reporting.
• Strong computer skills
• Critical thinking and problem solving abilities
• Ability to work on multiple projects
• Excellent communication and interpersonal skills.
• Knowledge of clinical trial design and Good Clinical Practices (GCP)
• Ability to understand and interpret primary and secondary objectives.
• Ability to routinely apply thorough detailed review of eCRF data
• Use of EDC (electronic data capture) systems to clean and manage data
Required Data Management Experience
• Building new Data Management Plans based on templates
• Identifying Critical Data Values used for analysis and reporting
• Implementing timely planning, design, and development of Case Report Forms
• Programming edit checks to query discrepant data, map data points and perform calculations
• Documenting eCRF completion guidelines.
• Managing testing and validation for new studies
• Performing standard and protocol-specified procedures for data preparation, including data cleaning and standardization
• Performing validation checks to ensure completeness and consistency of data
• Issuing queries to resolve errors and missing data
• Reconciling adverse event data
• Consulting with staff on data coding problems
• Delivering completed datasets
Clinical, Oncology, Query resolution, data collection, validation, CRF, patient charts
Additional Skills & Qualifications:
Minimum Education and Experience Requirements Bachelor’s degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions. One + year of data coordination.
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The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072