Clinical Research Coordinator 2

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

Preferred

• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred
• Must possess and maintain a valid California non-commercial Class C Driver's License
• Ability to drive day or night

Benefits

• Hybrid work arrangement
• Glassdoor
• 4.2
• Stanford University is a teaching and research university that focuses on graduate programs in law, medicine, education, and business.
• Stanford, California, USA
• http://www.stanford.edu
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Qualifications

• 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 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
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred
• Must possess and maintain a valid California non-commercial Class C Driver's License
• Ability to drive day or night
• Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

Required skills

• Association of Clinical Research Professionals Certification, California Class C Driver’s License, Clinical Practice, Clinical Research, FDA Regulations, HIPAA, Institutional Review Board Requirements, Medical Terminology, Microsoft Office, Research Protocols, Society of Clinical Research Associates Certification

Preferred skills

• Ability to drive day or night

Experience

• 2+ years