Job Description

• Provide comprehensive data management support to the Center for Cancer Research/CCR intramural clinical trials program.
• Manage the delivery of high-quality data from project start-up and planning to project execution and closeout.
• Independently perform project specific quality control and quality assurance tasks.
• Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practices, Good Clinical Data Management Practices, as well as SOPs and Working Instructions.
• Manage patient protocol information and review protocol and incorporate protocol-specific guidelines into the review of clinical trial data on several projects simultaneously.
• Contribute to the design of the databases and forms, ensuring they meet requirements for the entry and reporting of clinical data of varying complexity.
• Test new processes and systems for the management of data in clinical trials.
• Test clinical trial databases and data entry screens assuring compliance with protocol and institutional processes and procedures.
• Process, track and validate data accurately and on time.
• Perform data abstraction and data entry on several different protocols into multiple clinical research databases.
• Develop and extract patient clinical data reports for publications and presentations.
• Identify project specific reports and assist in the development of these reports.
• Prepare, review, and submit clinical data to monitoring agencies.
• Maintain client communication regarding data management project status and review key project questions with clients.

• BS in a related field and 6 years of clinical data management related experience.
• Demonstrated proficiency with data abstraction, query resolution, data reporting and analysis.
• 6 years in a medical, clinical or research related study.
• Proficiency with clinical databases and report tools.
• MS in a health-related field is a plus.
• Experience or knowledge of clinical or medical oncology research is a plus.
• MD, RN, MBA or BS with ongoing accreditation and certifications (CCRP) is a plus.

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