Supervisor Clinical Research: Cancer Research

Hoag•Irvine, CA

19h

About The Position

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.

Requirements

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.
Experience filing Institutional Review Board documents.
Broad knowledge and cross-functional understanding of clinical trial methodology.
Knowledgeable of Good Clinical Practices.
Knowledgeable of protection of human subjects in research practices.
Knowledgeable of FDA regulatory guidelines regarding clinical research.
Knowledgeable of responsibilities of Research Coordinator position.

Nice To Haves

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

Responsibilities

Oversee clinical research operational activities.
Ensure clinical research reflects best practices and industry standards.
Assist in ensuring proposed projects meet the mission and vision of Hoag and all Clinical Research stakeholders.
Supervise clinical research coordinators.
Assume Research Coordinator activities when other coordinator resources are at capacity or on leave.
Serve as the first point of contact for new physicians and sponsors regarding study start-up processes and training.
Oversee document recording, tracking, and updates of new clinical research study start-up processes (e.g., contracts, budgets, 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 all clinical research staff, including coaching, counseling, oversight of daily activities, performance reviews, and assisting with termination decisions.