Cancer Clinical Research Coordinator 2 – Gastrointestinal (GI) (Hybrid)

Duties

• Oversee and manage all aspects of clinical trials including industry and investigator initiated trials, including subsites, if applicable.
• Oversee subject recruitment and study enrollment goals.
• Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
• Manage data/oversee data management for research projects.
• Meet DSMC requirements for site management up to date.
• Develop and manage systems to organize, collect, report, and monitor data collection.
• Extract and analyze data.
• Maintain site regulatory file, per CCTO guidelines.
• Develop project schedules, keep targets, measurements, and accountabilities, as assigned.
• Occasionally lead team meetings and prepare/approve minutes.
• Formally mentor new staff or students, as assigned, participate in hiring process, prepare or assist 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/SRC/DSMC submissions, and respond to requests and questions.
• Collaborate with principal investigators, 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, Track patient and study specific milestones, review patient billing and invoice sponsors according to study contract. Ensure regulatory compliance.
• Regularly inspect study documents to ensure ongoing regulatory compliance.
• Manage audit preparation of clinical trials at Stanford and subsites.
• Provide oversight to subsites.
• 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

• Experience working with oncology clinical research studies.
• Minimum of 2 years of experience in a clinical research setting.
• Education & Experience: Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
• Knowledge, Skills And Abilities: Strong interpersonal skills. Proficiency with Microsoft Office and database applications. Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. Knowledge of medical terminology.
• Certifications & Licenses: Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.