Clinical Research Coordinator

Clinical Research CoordinatorSan Diego, CaliforniaResponsibilities:• Assists with study requirements per study guidelines and protocol.• Maintains stock of supplies needed to carry out protocol specific testing.• Assesses, stores, logs, and track study specific specimens in a secure location and or database.• Logs and tracks specimen samples and shipping.• Prepare, operates, and troubleshoot equipment required for study procedures.• Ability to read, understand, and follow SOPs, equipment manuals, and GCP.• Demonstrates an understanding of acceptable procedures and techniques and assists in modifications as directed.• Educates, prepares, gathers, and maintains appropriate communication with clinical research and/or CRO staff.• Develops strong working relationships clinical research staff engaged in research study activities.• Responsible preparing, tracking, and for mailing study kits required for various studies as assigned.• Maintain study information and database, records, analyzes, and runs various reports as directed.• Maintains stock, inventory, and orders office/laboratory supplies as required to support study specific protocol testing.• Corresponds with clinical research and/or CRO staff as required to support study protocol.• Ability to develop a variety of skills and knowledge in clinical protocol, ICH-GCP, and regulatory requirements.• Demonstrate commitment to the development, implementation and effectiveness of Sekisui Diagnostics’ Quality Management System per ISO, FDA, and other regulatory agencies.• Understand and is aware of the quality consequences which may occur from the improper performance of their specific job.• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.• Carry out duties in compliance with established policies.• Participate in research group meetings.