Supervisor Clinical Research : Molecular Therapy
About The Position
The Supervisor of Clinical Research (SCR) assists in overseeing clinical research operational activities and helps ensure research is conducted according to best practices and industry standards and aligns with Hoag’s mission and vision and the needs of Clinical Research stakeholders. The SCR supervises clinical research coordinators and may perform coordinator activities when other resources are at capacity or on leave. The role is the first point of contact for new physicians and sponsors regarding study start-up processes and training, and oversees recording, tracking, and updates of study start-up documents, including contracts, budgets, and informed consent materials. The SCR assists with developing and renewing clinical research policies and works with the Director of Clinical Research to resolve issues. The role requires knowledge of Good Clinical Practices, human-subject protection practices, FDA regulatory guidelines, and Research Coordinator responsibilities. The SCR also assists with recruitment and hiring and directly manages clinical research staff, including coaching, counseling, daily activity oversight, performance reviews, and assistance with termination decisions. Other duties may be assigned.
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 and experience filing Institutional Review Board documents.
- Broad knowledge and cross-functional understanding of clinical trial methodology.
- Knowledge of Good Clinical Practices, human-subject protection practices, FDA regulatory guidelines regarding clinical research, and Research Coordinator responsibilities.
Nice To Haves
- Minimum of 1 year of experience in a managerial or supervisory role preferred.
- Familiarity with medical areas of oncology, neuroscience, cardiovascular medicine, or orthopedic research preferred.
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 needs of Clinical Research stakeholders.
- Supervise clinical research coordinators and perform coordinator activities 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 documentation for new clinical research study start-up, including contracts, budgets, and informed consent.
- Assist with the development and renewal of clinical research policies.
- Work with the Director of Clinical Research on issues requiring problem-solving.
- Assist with recruitment and hiring.
- Directly manage clinical research staff, including coaching, counseling, oversight of daily activities, performance reviews, and assisting with termination decisions.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
