Clinical Research Coordinator 2 - (Cancer/Oncology)

Job Title: Clinical Research Coordinator 2. Location: Palo Alto, CA - hybrid Duration: 6 months contract on W2 Job Description: Conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies. CORE DUTIES: • 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 document 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. • Requirements: MINIMUM REQUIREMENTS: 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. Oncology (Cancer) treatment trials, Phase I, EPIC and onsite at a health institution (not looking for CRO or Pharma CRA experience) Knowledge, Skills and Abilities: • Strong interpersonal skills. • Proficiency in 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. 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. • Ability to drive day or night, if applicable. * - 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 the job.