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

About the Role

The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and 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 2 (CRC2) 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 healthcare in the cancer arena. Reporting to the Head and Neck Clinical Research Manager, the CRC2 will support clinical trials focused on endocrine and head and neck cancers, ensuring high-quality opportunities for patients.

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, including hiring, performance evaluations, and related duties.
• 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 budgets with staff and principal investigators, identifying standard of care versus study procedures. Track patient and study-specific milestones, and invoice sponsors according to study contracts.
• Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance.
• Work with principal investigators to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.

Requirements

• Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
• Experience working with oncology clinical research studies.
• Minimum of two years of experience in a clinical research setting.
• Proficiency in Microsoft Office and database applications.
• Experience with research protocols and regulatory or governing bodies, including HIPAA, FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
• Knowledge of medical terminology.
• Strong interpersonal skills.

Preferred Qualifications

• Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification.

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 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 their job.

Working Conditions

• May require working with or being 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.

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.