Cancer Clinical Research Coordinator - GU; Hybrid

Overview

Cancer Clinical Research Coordinator 2 - focused on NCTN trials for the GU group – (Hybrid)

The Stanford Cancer Institute (SCI) is one of a select number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country. The SCI seeks a Clinical Research Coordinator 2 to conduct clinical research focused on NCTN trials for the GU group and to support the mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach. The Cancer Clinical Trials Office (CCTO) supports the SCI by enabling translation of research from the laboratory into the clinical setting.

You will work with a leading team to advance cancer care and health outcomes.

Reporting to the Clinical Research Manager, the Clinical Research Coordinator 2 will oversee complex clinical research trials and align with the Institute's goals, mission and priorities. Candidates should have strong people and time management skills and a history of handling challenges with professionalism, initiative, and flexibility. The role requires independent coordination of complex research projects and experience in genitourinary (GU) oncology clinical research.

The CRC2 will independently manage significant aspects of at least one large GU study involving both surgery and chemotherapy, and will handle all aspects of several smaller studies.

Responsibilities include trial oversight and ensuring accrual targets are met.

Prior Experience In Genitourinary Oncology Clinical Trials Is Preferred.

• Oversee subject recruitment and study enrollment goals. Determine 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. Lead team meetings and prepare/approve minutes.
• Formally supervise, train, and/or mentor new staff or students, potentially including hiring, preparing or assisting with performance evaluations, and related duties, in addition to instruction on project work.
• Audit operations, including laboratory procedures, to ensure regulatory compliance; 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 investigator, identifying standard of care versus study procedures. Track patient and study milestones, and invoice sponsors according to study contract.
• Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance.
• Work with the principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable and ensure Institutional Review Board renewals are completed.
• Other duties may also be assigned.

Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

• Strong interpersonal skills.
• Proficiency with Microsoft Office and database applications.
• Experience with research protocols and regulatory bodies, including HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
• Knowledge of medical terminology.

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

• Frequently stand, walk, twist, bend, stoop, squat and use fine motor skills.
• Occasionally sit, reach above shoulders, perform desk-based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects up to 40 pounds.
• Rarely…