Senior Manager, Clinical Protocol Development

Beckman Research Institute

Under the direct supervision of the Senior Director, Clinical Research Services, the Senior Manager, Office for Clinical Protocol Development (OCPD) is responsible for the development, implementation, standardization, and coordination to support high quality COH investigator initiated research protocols and protocol related documents. The OCPD provides a central hub for COH investigators with regard to (a) provision of tools and templates for the research community, (b) provision of information (referrals and orientation sessions) to investigators and others regarding investigator initiated research, (c) provision of an array of clinical protocol development services, (e.g. protocol and consent document writing and editing, facilitating operational communications with industry partners and budget and contract analysts, shepherding research projects through the committee review process) (d) provision of study-specific electronic data capture design services and associated tools for investigator-initiated clinical research. All services focus on standardization and sensitivity to facilitate end-user needs, while also meeting the flexibility necessary to meet the large array of investigator research content. The OCPD Senior Manager, reports to and collaborates with the Senior Director, Clinical Research Services on a regular basis. To support COH investigators, the OCPD Director must also coordinate with other departments involved in the development and oversight and conduct of human subject research including the Clinical Trials Support Services, EPIC Content Administrators, Clinical Research Protections Office, Safety and Data Quality Office, Biostatistics and Research Informatics, Clinical Trials Office, and the Office of IND Development and Regulatory Affairs, Investigational Drug Services, and a variety of shared resources (e.g. Genomics core, Pharmacolocy core, Translational Research Lab) that provide services to researchers.

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