Clinical Data Coordinator

• Title: Clinical Data Coordinator
• Duration: 12 months
• Location: Chapel Hill, NC 27599

Job Description:

• 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.
• This role is fully onsite and supports clinical research activities conducted through the client’s Lineberger Comprehensive Cancer Center.

Essential Responsibilities:

• 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.

• Study Kit Management
• Clinical Trial Compliance & Quality Assurance
• Maintain working knowledge of assigned research protocols, sponsor requirements, and regulatory guidelines.
• Good Clinical Practice (GCP)
• FDA and federal regulations
• Institutional Review Board (IRB) requirements
• Client policies and procedures
• 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.
• Complete study registration requirements.
• 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.

• Training & Team Collaboration
• 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.

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.