Supervisor Clinical Research : Molecular Therapy

Hoag • Irvine, CA

20h

About The Position

The Supervisor of Clinical Research assists in overseeing clinical research operational activities and ensures that clinical research reflects best practices and industry standards. The position helps ensure proposed projects align with Hoag’s mission and vision and the interests of Clinical Research stakeholders. The supervisor oversees clinical research coordinators and may perform Research Coordinator duties when coordinator resources are at capacity or unavailable. The role is the first point of contact for new physicians and sponsors on study start-up processes and training, and oversees recording, tracking, and updating study start-up documents, including contracts, budgets, and informed consent. The supervisor also assists with clinical research policy development and renewal, works with the Director of Clinical Research to resolve issues, and manages clinical research staff. The role requires knowledge of Good Clinical Practices, human-subject protections, FDA regulatory guidelines, and Research Coordinator responsibilities.

Requirements

• Minimum of 3 years of experience in the field or a related area.
• Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines.
• Understanding of clinical trial methodologies.
• Experience filing Institutional Review Board documents.
• Broad knowledge and cross-functional understanding of clinical trial methodology.
• Knowledge of Good Clinical Practices, protection of human subjects in research, FDA regulatory guidelines, and Research Coordinator responsibilities.

Nice To Haves

• Minimum of 1 year of experience in a managerial or supervisory role.
• Familiarity with medical areas of oncology, neuroscience, cardiovascular medicine, or orthopedic research.

Responsibilities

• Assist in overseeing clinical research operational activities and ensure research reflects best practices and industry standards.
• Help ensure proposed projects align with Hoag’s mission and vision and the interests of Clinical Research stakeholders.
• Supervise clinical research coordinators and assume coordinator duties when resources are at capacity or coordinators are on leave.
• Serve as the first point of contact for new physicians and sponsors regarding study start-up processes and training.
• Oversee recording, tracking, and updating documents for new clinical research study start-up, including contracts, budgets, and informed consent.
• Assist with development and renewal of clinical research policies.
• Work with the Director of Clinical Research to resolve issues requiring problem-solving.
• Assist with recruitment and hiring and directly manage clinical research staff, including coaching, counseling, oversight of daily activities, performance reviews, and assistance with termination decisions.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed