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.

Qualifications

• 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.

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.
• 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, if applicable.