Clinical Research Coordinator Job at Astera Cancer Care in Roseville

At The Cancer & Hematology Centers we are dedicated to help, healing, and hope for cancer patients and their families. We provide advanced treatments, innovative research, and compassionate care. Our patients receive comprehensive, contemporary cancer care balanced with the support of a dedicated nursing and healthcare team, including oncology-certified nurses, social workers, lab and pharmacy personnel, and psychologists.

About the role

The Clinical Research Coordinator is responsible for the day-to-day functions of research clinical trials. This includes obtaining trials, screening and consenting patients, educating staff on available trials, data management, drug accountability, and regulatory document management. This position supports expanding research efforts at our Roseville location.

Schedule

Monday to Friday, 7:30 AM to 4:00 PM. No weekends or holidays.

Responsibilities

• Screen daily for potential patients and communicate with physicians and staff about potential and active patients.
• Manage study drug and laboratory supplies.
• Serve as a liaison for enrolled clinical trial patients to address concerns, facilitate study treatment assessments, attend patient doctor visits, capture and report adverse events, coordinate logistical requirements (e.g., radiology tests), and educate nursing staff on protocol requirements.
• Ensure completion of all study-required assessments.
• Process, catalog, and ship biologic samples to central laboratories as required by clinical trials.
• Ensure clinical trial documentation meets FDA requirements.
• Assist investigators, field clinical staff, clinical research organizations, and sponsor companies in collecting data in a timely manner that meets protocol requirements.
• Assist in the maintenance of current/pending regulatory documents in conjunction with the regulatory coordinator.
• Organize and file clinical research essential documentation.
• Systematically organize data to allow for efficient and accurate clinical reports.
• Communicate with research sponsor companies via telephone/email regarding the status and progress of clinical trials, patient screening efforts, and enrollment.
• Maintain the current status of research protocols, updating, amending, and interpreting as necessary, and communicate changes to the healthcare team.
• Develop required study materials according to guidelines and regulatory requirements, and facilitate protocol approval/re-approval.
• Maintain databases and systems for patient enrollment data, patient files, statistical data, and other pertinent study information.
• Participate in ongoing process improvement activities, including data management and programmatic improvements.
• Manage and document incoming clinical trial payments and invoiceables.
• Serve as a conduit between the Sponsor and the practice’s reimbursement department to ensure accurate and timely receipt of payments, tracking them according to negotiated contracts and budgets.
• Participate in the audit process by preparing patient records and follow-up as necessary.
• Function as a team member by expanding responsibilities as directed to facilitate optimal workflow within the cancer center.
• Communicate and interact with peers and other departments to positively impact patient services and staff morale.
• Interact effectively with patients and family members, demonstrating sensitivity to cultural diversity, age-specific needs, and confidentiality.

Requirements

• Bachelor’s degree in health/biomedical sciences, health administration, biology, or chemistry (preferred).
• 2 years of research experience; clinical oncology research highly preferred.
• Working knowledge of medical and pharmaceutical terminology.

Access to Medical Records

This role requires access to the following parts of the medical record: Lab Information System, Pharmacy Information System, Entire Chart/Electronic Medical Record (EMR), Clinical Trial Management System (CTMS), and Electronic Billing System (EBS).