Clinical Data Coordinator

The Data Coordinator I supports oncology clinical research by ensuring the accurate collection, abstraction, review, and submission of clinical trial data. This position independently manages data-related activities for multiple studies throughout the clinical trial lifecycle, including startup, implementation, monitoring, and closeout. Working closely with study coordinators, investigators, regulatory staff, sponsors, and clinical teams, the Data Coordinator helps maintain data integrity, support protocol compliance, and ensure high-quality research operations in accordance with Good Clinical Practice (GCP), federal regulations, sponsor requirements, and institutional policies. --- Data Management & Collection Abstract clinical information from medical records and source documents according to study-specific requirements. Collect, review, and enter clinical trial data into electronic data capture systems and case report forms. Ensure data accuracy, completeness, and timely submission. Resolve data queries within sponsor-required timelines. Maintain research patient records and study documentation. Compile research charts and supporting documentation for enrolled participants. Track serious adverse events and associated follow-up information. Manage competing priorities, database deadlines, and data lock requirements. Create and review source documentation worksheets to support accurate data collection. Archive study records in accordance with FDA and institutional requirements. Clinical Trial Compliance & Quality Assurance Maintain working knowledge of assigned research protocols, sponsor requirements, and regulatory guidelines. Ensure study activities comply with: Good Clinical Practice (GCP) FDA and federal regulations Institutional Review Board (IRB) requirements Prepare study documentation for monitoring visits and audits. Assist with audit responses, CAPA plans, and root cause analyses. Review monitoring reports and identify trends requiring follow-up. Support electronic system validation and quality assurance activities. Collaborate with regulatory staff and study teams to ensure protocol adherence. Participate in study startup, initiation, monitoring, and closeout meetings. Human Subject Protection Verify participant eligibility according to protocol and regulatory requirements. Review medical records, screening information, and study documentation to support enrollment decisions. Support safe handling and shipment of research specimens. Assist study teams in maintaining participant safety and protocol compliance. Clinical Trial Systems & Financial Support Enter study participants into OnCore and other research systems within required timelines. Maintain patient calendars and study records within the Clinical Trial Management System. Support accurate patient and sponsor billing processes. Communicate billing questions and discrepancies to appropriate finance personnel. Assist in maintaining compliance with clinical trial financial processes. Work closely with investigators, clinical coordinators, regulatory staff, sponsors, and research leadership. Serve as a resource and mentor for new team members. Assist with staff training and onboarding activities. Support the development of investigator-initiated trials and study-specific case report forms. Participate in departmental process improvement initiatives and training programs. --- Minimum Qualifications Bachelor's degree or an equivalent combination of education and experience. Degree must be obtained from an accredited institution. Preferred Qualifications At least one year of Data Coordinator experience or equivalent oncology clinical research experience. Experience supporting therapeutic clinical trials involving investigational drugs and/or medical devices. Experience with Phase I, II, or III clinical trials. Knowledge of ICH-GCP guidelines, federal regulations, and protocol-driven research. Experience navigating electronic medical records and performing data abstraction. Strong data entry, documentation, and quality control skills. Experience working with Clinical Trial Management Systems such as OnCore. Ability to manage multiple research studies simultaneously while meeting strict deadlines. Strong computer proficiency and database management skills. Excellent written and verbal communication skills. Strong organizational skills and attention to detail. Ability to work effectively in a collaborative team environment. #J-18808-Ljbffr