|The Research Compliance Analyst 2 (RCA-2) position involves staffing, administering or managing oversight and compliance committee activities related to human subjects research. The Research Compliance Analyst 2 reviews minimal risk research protocols participates in reviewing protocols, and supports institutional compliance with federal, state and University mandated laws, regulations, and policies. Ã¯ Applies research compliance professional concepts to pre-review and review of minimal risk research protocols to ensure that all federal and state regulatory criteria are met as well as UCOP and UCB policies for determinations of exemption and/or expedited approval by the IRB. Ã¯ Provide support for special projects as assigned by Director. Ã¯ Communicates directly with investigators to resolve all concerns and get clarification as identified during the review process. Ã¯ Communicates and consults with researchers prior to protocol submission and provides guidance on how to resolve particular issues of concern and meet requirements of external regulatory bodies through standard office processes (e.g. email, phone, consultative appointments) to provide general customer service. Ã¯ Support senior staff as requested (e.g. meeting set-up and processing reimbursements). Ã¯ Participates in the development and revision of standard operating procedures and guidelines. Ã¯ Properly documents all actions in accordance with all applicable laws, regulations, policies, and procedures |
The Research Compliance Analyst 3 position involves staffing, administering or managing oversight and compliance committee activities related to human subjects research. The Research Compliance Analyst 3 pre-reviews and/or reviews minimal research protocols, advises on writing protocols and supports institutional compliance with federal, state and University mandated laws, regulations, and policies. Ã¯ Applies research compliance professional concepts to review and pre-review of routine and complex research protocols; applies human subjects federal regulations, state regulations, and University policies to protocol review; and documents campus compliance with regulatory and policy standards. Ã¯ Provides pre-submission guidance on preparing and revising research applications. This may include communicating with researchers and providing guidance on how to resolve particular issues and meet requirements of external regulatory bodies Ã¯ Propose and draft plans, projects, improvements and/or activities that will enhance the human research protection program for the institution. Ã¯ Determines appropriate level of review. Ã¯ Work on special projects as assigned by Director. Ã¯ Participates in general administrative support of office with customer service (e.g. general email, answering phone calls, full committee meeting support). Ã¯ Participates in educational outreach to classes, seminars or departments on human subject research regulations, IRB processes, forms, and policies. Ã¯ Research (including benchmarking), recommend and draft guidance, and proceduresResearch Compliance Analyst 2 level : Ã¯ Requires initiative, planning and decision-making abilities to complete assigned duties. Ã¯ Demonstrated abilities as a self-directed learner to gain knowledge of new topics such as Federal and State regulations, and policies pertaining to research subjects. Ã¯ Proficiency with computers, including ability to operate personal computer software (for example, Word, Access and Excel, email, electronic calendaring, internet, et cetera) with sophisticated retrieval, storage, and merging capabilities and the ability to quickly learn new software. Ã¯ Excellent customer service skills, pleasant, helpful, a good listener, and patient. Ã¯ Time management skills and the flexibility to accommodate changing priorities in unit. Ã¯ Effective, efficient and tactful oral and written communication skills demonstrating the ability to summarize and concisely convey concepts, information and recommendations. Ã¯ Ability to work in a team-oriented setting, to prioritize work, and to follow through on routine assignments with minimal direction as well as back-up colleagues as needed. Ã¯ Strong organizational skills, the ability to multi-task, and work with frequent interruptions. Ã¯ Ability to problem-solve issues; listen, interpret and confirm understanding of others' communications; and, to be objective. Ã¯ Recognize when more knowledgeable staff or other campus units (e.g. SPO, CLEB, COI) should be consulted and/or contacted.
Education/Training: Ã¯ Bachelor degree in a pertinent discipline and/or experience/training in an similar field.
Research Compliance Analyst 3 level : Ã¯ Demonstrates self-discipline, initiative and consistently sound, independent judgment completing complex assignments. Ã¯ Thorough knowledge and ability to apply all of the federal, state, and university regulations, policies, and guidelines for the protection of human subjects and federal guidance documents. Ã¯ Working knowledge of and/or experience with quantitative and qualitative research design; scientific research concepts and terminology. Ã¯ Self-motivated and striving for continuous self-improvement; actively engaging in self-directed learning related to professional development. Ã¯ Demonstrated proficiency in public speaking, writing and contributes to web site maintenance. Ã¯ Demonstrates efficient and effective use of time minimizing the time taken for the review and approval process to be completed. Ã¯ Organized and able to effectively multi-task on multiple protocols and/or projects and complete all tasks on time. Ã¯ At least two years full-time experience in a compliance position, preferably directly in a HRPP or IRB office. Education/Training: Ã¯ Bachelor degree in a pertinent discipline and/or experience/training in an similar field.