Clinical Research Data Coordinator

About the role

The Clinical Research Data Coordinator plays a crucial role in managing clinical trial data, ensuring its accuracy and integrity across various databases. This position involves developing data collection tools and guidelines, supporting oncology clinical trials from Phase I to III, and resolving complex data issues.

Responsibilities

• Enter clinical research data from source documents into computer systems and EDC platforms with a high level of accuracy and completeness.
• Verify all data entries to ensure they conform to established protocols, data standards, and regulatory requirements.
• Maintain existing databases used for oncology clinical trials and develop guidelines to ensure ongoing data integrity.
• Integrate data from several sources, including medical charts, clinical trial documentation, and EDC systems, to create complete and consistent records.
• Identify, interpret, and select usable data from subtle and complex data patterns, applying practical understanding of clinical research and oncology.
• Utilize computer applications and EDC tools (such as Medidata) to manipulate, manage, and report complex clinical trial data.
• Develop new tools, templates, or processes to assist with data collection, data review, and analysis for treatment oncology trials.
• Work closely with data providers, such as clinical research staff and investigators, to discuss and clarify data ambiguities, inconsistencies, and missing information.
• Perform audits of your own work and, when required, the work of others to ensure conformance with established procedures and data quality standards.
• Select and apply appropriate formulas, computer programs, or applications depending on data content and reporting needs.
• Resolve complex data queries within oncology trials, meeting expectations for daily query resolution (for example, resolving 20–30 queries in an 8-hour day depending on complexity).
• Conduct chart reviews to extract relevant clinical information needed for trial documentation and data entry.
• Pre-screen patients against protocol eligibility criteria and document findings accurately in study systems.
• Provide administrative support related to clinical trial documentation, data filing, and coordination as needed.

Essential Skills

• Demonstrated experience working with treatment oncology clinical trials, preferably across Phase I–III studies.
• Strong clinical research experience with familiarity in oncology and gastrointestinal (GI) oncology studies.
• Heavy electronic data capture (EDC) experience, specifically with Medidata or comparable platforms.
• Proven ability to perform accurate and efficient data entry within Medidata and other clinical trial databases.
• Ability to resolve complex data queries in oncology trials while meeting stringent timelines and productivity expectations.
• Experience with chart review to identify, extract, and interpret relevant clinical information for trial data.
• Experience with pre-screening patients for clinical trials based on protocol criteria.
• Proficiency with computer applications used for data manipulation, reporting, and database maintenance.
• Experience establishing and following complex record-keeping procedures and data integrity guidelines.
• Strong attention to detail and accuracy in handling subtle and complex data patterns.
• Capacity to exercise independent judgment and initiative in daily tasks and problem-solving.
• Able to communicate clearly with data providers and clinical teams to clarify data ambiguities and inconsistencies.

Additional Skills & Qualifications

• Experience overseeing multiple concurrent oncology studies, particularly GI oncology trials.
• Familiarity with clinical trial workflows, documentation standards, and query management processes.
• Experience developing tools, templates, or guidelines to support data collection and analysis.
• Experience performing data audits and quality checks to ensure conformance with established procedures.
• Strong organizational skills and the ability to manage high volumes of data and queries within defined timelines.
• Ability to perform data audits and quality checks to ensure conformance with established procedures.
• Comfort working with complex formulas, computer programs, or applications to support data reporting.
• Administrative support experience in a clinical research or academic medical environment.