Clinical Research Coordinator - Oncology

Clinical Research Coordinator - Oncology

The Clinical Research Coordinator (CRC) is responsible for the independent coordination and management of assigned oncology and hematology clinical research studies while ensuring patient safety, protocol compliance, regulatory compliance, and data integrity. The CRC serves as the primary coordinator for assigned clinical trials and research participants, overseeing all study-related activities from patient screening through study completion and close-out.

The CRC is expected to maintain ownership of assigned studies and research participants by coordinating protocol required visits, treatment schedules, study procedures, laboratory collections, sponsor communications, monitor visits, data entry, query resolution, adverse event reporting, and study documentation. The CRC collaborates closely with physicians, advanced practice providers, nurses, laboratory personnel, regulatory staff, research assistants, sponsors, CROs, and monitors to ensure studies are conducted in accordance with study protocols, FDA regulations, ICH-GCP guidelines, HIPAA, sponsor requirements, and CBSC policies and procedures. The CRC is accountable for the operational success of assigned studies and is expected to proactively identify, communicate, and resolve issues while maintaining an audit-ready environment.

Essential Job Functions

• Study Coordination
• Patient Management
• Participant Screening and Enrollment
• Study Documentation and Data Management
• Data Queries and Discrepancy Resolution
• Monitor, Sponsor, and CRO Communication
• Regulatory Compliance
• Safety Reporting
• Laboratory and Study Procedure Coordination
• Collaboration and Teamwork
• Multi-Site Research Support
• Quality Assurance
• Problem Solving and Process Improvement
• Professional Development
• Other Duties

Qualifications and Experience

• Bachelor's degree in Life Sciences, Nursing, Healthcare Administration, Public Health, or a related field preferred.
• Minimum of three (3) to five (5) years of Clinical Research Coordinator experience in oncology and/or hematology clinical research required.
• Demonstrated experience coordinating Phase I-IV oncology clinical trials in a community oncology practice, academic medical center, or similar clinical research environment.
• Strong working knowledge of FDA regulations, ICH-GCP guidelines, HIPAA, informed consent requirements, human subject protection, and clinical research regulatory standards.
• Experience utilizing Electronic Data Capture (EDC) systems, CTMS platforms, electronic medical records, and sponsor portals.
• Thorough understanding of oncology treatment regimens, protocol-required assessments, laboratory procedures, adverse event reporting, concomitant medication documentation, and protocol compliance.
• Ability to independently manage multiple clinical trials, competing priorities, and sponsor deadlines while maintaining exceptional attention to detail.
• Excellent organizational, communication, critical thinking, and problem-solving skills.
• Ability to build and maintain professional relationships with physicians, patients, sponsors, Contract Research Organizations (CROs), monitors, and multidisciplinary healthcare teams.
• Ability and willingness to travel between CBSC clinic locations throughout Los Angeles and Orange County as operational needs require.
• Current Good Clinical Practice (GCP) and Human Subjects Protection training preferred.

Working Conditions and Physical Requirements

• Work is primarily performed in an outpatient oncology and hematology clinical environment with frequent interaction with physicians, nurses, patients, sponsors, monitors, and research personnel.
• Frequent use of computers, electronic medical records, Electronic Data Capture systems, and other research software platforms.
• Ability to sit, stand, walk, bend, reach, and lift up to 25 pounds as needed throughout the workday.
• Ability to travel between CBSC clinic locations throughout Los Angeles and Orange County to support research operations.
• Occasional schedule flexibility may be required to accommodate monitor visits, sponsor meetings, patient schedules, or study-related deadlines.