Cancer Clinical Research Coordinator Associate – Pediatric Oncology/Liquid Tumor (Hybrid)

The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University. We seek a Clinical Research Coordinator Associate to help enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach.

The Clinical Trials Office (CTO) is an integral component of the Stanford Cancer Institute, enabling the translation of research from the laboratory into the clinical setting. You will work with an unparalleled leading-edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena. Reporting to the Clinical Research Manager for Pediatric Oncology, this role supports early phase clinical research studies in Pediatric Oncology.

Responsibilities

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through close-out.
• Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study-related documents, and complete study documents/case report forms.
• Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions and ensure Institutional Review Board renewals are completed.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
• Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
• Participate in monitor visits and regulatory audits.
• Work collaboratively with the research team and clinical teams to help manage participant screenings, consent process, study procedures, IRB protocol compliance, and general communication with both internal and external stakeholders.

Requirements

• Two-year college degree and two years related work experience or a bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.
• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.
• Must possess and maintain a valid California non-commercial Class C Driver's License. Ability to drive day or night. When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.

Qualifications

• Knowledge of the principles of clinical research and federal regulations.
• Familiarity with IRB guidelines and regulations.
• Previous experience with clinical trials.
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

Physical Requirements

• Frequently stand, walk, twist, bend, stoop, squat, and use fine light/fine grasping.
• Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone, and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.

Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

Working Conditions

• Occasional evening and weekend hours.

Work Standards

• Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures.