Cancer Clinical Research Coordinator 2 – Head and Neck Oncology CRG (Hybrid)

About the role

The Stanford Cancer Institute (SCI) is a National Cancer Institute-Designated Comprehensive Cancer Center located within the Stanford University School of Medicine. It is a dynamic and growing institute that collaborates with faculty across multiple schools and departments to advance cancer research, treatment, education, and outreach.

Responsibilities

• Oversee subject recruitment and study enrollment goals.
• Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
• Oversee data management for research projects.
• Develop and manage systems to organize, collect, report, and monitor data collection.
• Extract, analyze, and interpret data.
• Develop project schedules, targets, measurements, and accountabilities, as assigned.
• Lead team meetings and prepare/approve minutes.
• Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
• Monitor Institutional Review Board submissions and respond to requests and questions.
• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
• Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
• Develop study budget with staff and principal investigator, identifying standard of care versus study procedures.
• Track patient and study specific milestones, and invoice sponsors according to study contract.
• Ensure regulatory compliance.
• Regularly inspect study documents to ensure ongoing regulatory compliance.
• Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable.
• Ensure Institutional Review Board renewals are completed.

Qualifications

• Society of Clinical Research Associates or Association of Clinical Research Professionals certificate is preferred.
• Experience working with oncology clinical research studies.
• Minimum of two (2) years of experience in a clinical research setting.

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.

Working Conditions

Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections. May require extended or unusual work hours based on research requirements and business needs.

Working Standards

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: 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, including but not limited to the personnel policies and other policies found in the University's Administrative Guide.