Supervisor Clinical Research: Digestive Health Clinical Research

Responsibilities

• Assists in overseeing clinical research operational activities, ensuring adherence to best practices and industry standards.
• Ensures proposed projects align with the mission and vision of Hoag and all Clinical Research stakeholders.
• Supervises clinical research coordinators and assumes Research Coordinator activities when 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.
• Oversees document recording, tracking, and updates for new clinical research study start-up processes (e.g., contracts, budgets, informed consent).
• Assists with the development and renewal of clinical research policies.
• Collaborates with the Director of Clinical Research on problem-solving for issues that arise.
• Must be knowledgeable of Good Clinical Practices, protection of human subjects in research, and FDA regulatory guidelines regarding clinical research, as well as the responsibilities of the Research Coordinator position.
• Assists with recruitment, hiring, and directly manages all clinical research staff, including coaching, counseling, oversight of daily activities, performance reviews, and assisting with termination decisions.
• Performs other duties as assigned.

Requirements

• Minimum of 3 years of experience in clinical research or a related field.
• 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 year of experience in a managerial/supervisory role (preferred).
• Familiarity with medical areas such as oncology, neuroscience, cardiovascular medicine, or orthopedic research (preferred).