Supervisor Clinical Research: Digestive Health Clinical Research

This is an on-site position in Irvine and Newport Beach - primarily sitting in Newport Beach.

Primary Duties and Responsibilities

The Supervisor of Clinical Research (SCR) assists in overseeing clinical research operational activities. The SCR assures all clinical research conducted reflects best practices and industry standards. Assists in ensuring that proposed projects meet the mission and vision Hoag and all Clinical Research stakeholders.

The SCR supervises clinical research coordinators. Assumes Research Coordinator activities when other coordinator resources are at capacity, or on leave. Serves as the first point of contact for new physicians and sponsors regarding study start-up processes and training. Responsible for oversight of document recording, tracking and updates of new clinical research study start-up process (i.e. contracts, budgets, informed consent, etc.). Assists with development and renewal of clinical research policies. Works with Director of clinical research on issues requiring problem-solving. Must be knowledgeable of Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research as well as responsibilities of Research Coordinator position.

Will be responsible for assisting with recruitment and hiring, and directly managing all clinical research staff including coaching, counseling, oversight of daily activities, performance reviews as well as assisting with termination decisions. Performs other duties as assigned.

Education and Experience

• Minimum of 3 years of experience in the field or in a related area
• Working knowledge of FDA, NIH and OHRP regulatory requirements and ICH GCP guidelines. Understanding of clinical trial methodologies and experience filing Institutional Review Board documents
• Broad knowledge and cross-functional understanding of clinical trial methodology
• Minimum of 1 years of experience in a managerial/supervisory role preferred
• Familiar with medical areas of oncology, neuroscience, cardiovascular medicine or orthopedic research preferred