Job Title: Oncology CRC

Work Location: Orange County, CA

Summary:

The Oncology Clinical Research Coordinator is responsible for independently managing clinical research studies, ensuring compliance with regulatory requirements, and supporting patient enrollment and data integrity. This role involves collaboration with medical staff, accurate documentation, and participation in training and quality improvement initiatives. The position requires travel between multiple offices within the county and a 6-week training period at a designated location.

Responsibilities:

• Independently coordinate clinical research studies, including patient screening for protocol eligibility and participation in the informed consent process.
• Schedule and manage patient research visits and procedures, ensuring timely and accurate documentation of all study-related activities.
• Collaborate with medical personnel to document patient condition changes, adverse events, medication use, and protocol compliance on Case Report Forms (CRFs).
• Maintain accurate source documents and ensure timely data collection, entry, and reporting, including prompt responses to sponsor queries.
• Compile and present study-related information such as protocol activity, accrual data, and workload at regular research meetings.
• Ensure compliance with federal and local regulations, including FDA and IRB requirements, and maintain Good Clinical Practice (GCP) standards.
• Assist with patient research billing, reconciliation, and participate in monitoring, auditing, and centralized activities such as SOP development.
• Identify and implement strategies to increase patient enrollment, improve research efficiency, and support training and education of staff.

Qualifications:

• Minimum of 1 year clinical research coordination experience required, with oncology experience preferred.
• BA/BS degree preferred.
• ACRP/SoCRA (or equivalent) certification preferred.
• Strong knowledge of Good Clinical Practice (GCP) guidelines and HIPAA regulations.
• Ability to travel between multiple office locations within the county as needed.
• Excellent organizational, communication, and documentation skills.
• Experience with regulatory compliance and working with Institutional Review Boards (IRB).
• Commitment to maintaining patient confidentiality and high ethical standards.

Published Category: Clinical Operations & Development