The incumbent is responsible and accountable for ensuring all protocol related regulatory processes and procedures are maintained for both new and existing cancer research clinical trials. The incumbent drafts all relevant IRB (Institutional Review Board) and National Cancer Institute (NCI) cooperative group submission documentation in a timely manner. Utilizes all necessary software programs for this purpose. Prepares annual continuing review reports for all protocols and ensures they are submitted by the required due date. The incumbent is responsible for processing all protocol amendments, notices, suspensions, terminations, advertisements, and internal and external safety reports, (adverse event reports) for IRB submission. Responsible for drafting all protocol related consents following strict guidelines given by both study sponsors and IRB's. The incumbent is accountable for maintaining and keeping program regulatory files current, neat and in order, and maintaining all databases and tracking systems in place for these activities. Keep affiliates apprised of protocol updates and answer protocol specific questions. Work with Principal Investigators via support of new study opening, sign off of regulatory documents and guidance on systems associated with this role.
Maintenance and updating of the online intranet site on strict timelines for incumbent's assigned studies cancer research program coupled with databases and web-sites will be an integral aspect of this position. A clinical trials management system will be maintained by this position. Other regulatory support assignments from the Director will be a component of this position in support of compliance such retrieving billing related documentation, etc. As a member of a Sutter CRC support services function, will act as regulatory ambassador for the program and provide customer friendly and responsive job responsibilities in support of program customers.
Education High School Diploma Experience0-2 years prior clinical trial research experience preferred. Prior regulatory experience strongly preferred. Experience working closely and collaboratively with physician investigators and Institutional Review Boards is highly preferred. Experience in oncology is preferred. KnowledgeFamiliarity with health care organizations providing research trial options to patients is strongly preferred. Excellent knowledge of the requirements of maintaining compliance for large clinical trial research operations is preferred. English language including correct use of spelling, grammar and punctuation is required, as well as the ability to maintain study compliance in a regulatory environment. Demonstrated knowledge of complex organizations, with an emphasis on research environments is desirable. The ability to effectively establish priorities and meet deadlines when receiving work is required. Capacity to handle multiple tasks simultaneously is required. Demonstrated knowledge of standard office systems, equipment, processes and procedures is required.
Special SkillsProven advanced skills in word processing is required. Must have demonstrated communication skills (written and oral). Must have strong organizational and problem-solving skills and have the ability to balance numerous priorities in a given time. Must be detail-oriented, self-directed, and be able to work with minimal supervision. Must have demonstrated ability to deal with confidential information, and have the ability to demonstrate tact, diplomacy and a high level of professionalism. Must have well developed skill using word processing, spreadsheet and some database input is required; experience with Word, Outlook, Excel is required and experience with online regulatory computer systems is strongly preferred. Business Conduct: Follows the Business Codes and Conducts of Sutter Health Home office and maintain good working attitude and relationships with supervisor and co-workers. Affiliate staff are our customers and should be considered as such. We treat everyone with respect in our work, with a high ethic for professionalism and maintaining our integrity and honesty in all that we do and communicate. In a fast paced environment will often work under deadlines and the position requires the capacity for good time management for the high volume of work required.