Clinical Research Coordinator - Oncology

CLINICAL RESEARCH COORDINATOR

JOB PURPOSE

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

1. Study Coordination

• Coordinate and independently manage all aspects of assigned Phase I-IV oncology and hematology clinical trials from patient screening through study close-out. Ensure all study activities are completed in accordance with protocol requirements, sponsor expectations, Good Clinical Practice (GCP), FDA regulations, and CBSC Standard Operating Procedures.

1. Patient Management

• Serve as the primary research contact for assigned study participants throughout their participation in clinical trials. Coordinate all protocol-required visits, treatments, laboratory testing, imaging, follow up appointments, survival follow-up, and study procedures while ensuring continuity of care and protocol compliance.

1. Participant Screening and Enrollment

• Review medical records and patient history to identify potentially eligible participants. Coordinate screening activities, verify eligibility criteria, facilitate the informed consent process as delegated by the Principal Investigator, and ensure all protocol requirements are satisfied prior to enrollment and treatment.

1. Study Documentation and Data Management

• Maintain complete, accurate, and contemporaneous source documentation for all assigned studies. Complete electronic Case Report Forms (eCRFs), Electronic Data Capture (EDC) systems, sponsor portals, CTMS documentation, study logs, and other required research documentation within sponsor-required timelines while maintaining an audit-ready study file.

1. Data Queries and Discrepancy Resolution

• Review, investigate, and resolve sponsor-generated data queries, monitor findings, and documentation discrepancies promptly. Work collaboratively with physicians, research staff, regulatory personnel, sponsors, and monitors to ensure data accuracy, completeness, and protocol compliance.

1. Monitor, Sponsor, and CRO Communication

• Serve as the primary point of contact for assigned sponsors, Contract Research Organizations (CROs), and study monitors. Coordinate and facilitate Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), Close-Out Visits (COVs), audits, and sponsor communications. Ensure all monitor action items and follow-up requests are completed within required timelines.

1. Regulatory Compliance

• Ensure assigned studies remain compliant with all protocol requirements, FDA regulations, ICH-GCP guidelines, HIPAA, sponsor requirements, and institutional policies. Collaborate with the Regulatory Department to support protocol amendments, continuing reviews, safety reporting, investigator documentation, delegation logs, and essential regulatory documents as needed.

1. Safety Reporting

• Identify, document, and report Adverse Events (AEs), Serious Adverse Events (SAEs), protocol deviations, unanticipated problems, and other safety events in accordance with sponsor, protocol, and regulatory reporting requirements. Ensure timely communication with investigators, sponsors, and appropriate regulatory personnel.

1. Laboratory and Study Procedure Coordination

• Coordinate protocol-required laboratory collections, specimen processing, laboratory kit management, shipment requirements, imaging studies, and other study procedures. Collaborate with laboratory staff, pharmacy, nursing, and external vendors to ensure protocol compliance.

1. Collaboration and Teamwork

• Work collaboratively with physicians, advanced practice providers, nurses, research assistants, regulatory coordinators, laboratory personnel, schedulers, pharmacy staff, and administrative departments to ensure efficient study execution. Provide guidance and support to research assistants and assist with training as appropriate.

1. Multi-Site Research Support

• Provide research coverage and operational support across CBSC clinic locations as assigned. Travel between Los Angeles and Orange County offices as necessary to support patient care, study operations, monitor visits, and departmental needs.

1. Quality Assurance

• Maintain an audit-ready environment by ensuring study documentation, source records, delegation logs, subject files, regulatory documentation, investigational product accountability, and protocol documentation remain accurate, complete, and inspection-ready at all times.

1. Problem Solving and Process Improvement

• Proactively identify operational challenges, protocol concerns, scheduling conflicts, patient issues, documentation deficiencies, and workflow inefficiencies. Develop solutions and communicate concerns promptly to Research Management and Investigators while participating in departmental

quality improvement initiatives.

1. Professional Development

• Maintain current knowledge of oncology clinical research, applicable regulations, sponsor requirements, Good Clinical Practice (GCP), and departmental Standard Operating Procedures.

• Complete all required training and continuing education as assigned.

1. Other Duties

• Perform other duties, special projects, and responsibilities as assigned to support the Research Department and organizational operations.

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.

DIRECT REPORTS

This position has no direct supervisory responsibilities but is expected to work collaboratively with Research Assistants, Regulatory Coordinators, Data Quality personnel, Research Billing, laboratory staff, nurses, physicians, and other members of the multidisciplinary research team. The Clinical Research Coordinator may provide guidance, mentorship, and training to Research Assistants and other research personnel as assigned.

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