IRB Officer, Cedars-Sinai, LA, CA Browning, Lynzee Engel 10 Dec 1999 22:04 EST
Cedars-Sinai Health System, Los Angeles, CA CSMC Burns & Allen Research Institute - within a JCHO Accredited, premier, private, non/profit medical center, currently with over $46M in sponsored research, and over 1000 IRB applications annually has the following position available. IRB Officer New position in the expanding IRB Office. Experienced IRB Staff desired! Salary Range: $36,500 to $60,000 /Yr., Based on Experience & Ability/Knowledge. Open until filled. Summary: Under Manger's general guidance, supports one of two IRB Chairs and one of two Institutional Review Boards (IRB) with meetings and administrative processes according to regulation. Provides timely and accurate guidance to Research Investigators and staff with application preparation to obtain and maintain timely review and approval. Develops and conducts in-service training annually. Requires customer service orientation, accurate interpretation of PHS, FDA and other regulations with the judgment to obtain validation when necessary. Recommends development or modification of institutional policies & procedures as they apply to IRB. Essential Duties: IRB Review Process - Contributes significant administrative comments to pre-review of new IRB applications. Tracks applications, annual reports, and modification requests. Maintains documentation to meet audit standards. Must know, understand, and keep current of all regulatory and ethical issues governing the structure, functions, and requirements of the IRB. Initiates accurate, timely and concise official correspondence and reports as required by IRB action and regulation. Establishes agendas and produces official minutes of all meeting (Pre-review, IRB, or as requested) to the satisfaction of the IRB and Chair. Attend and participate in appropriate meetings (supportive of the Chair and as an advocate for protection of research subjects). Coordinate IRB functions with other areas of the Research Institute to facilitate relevant communication and required documentation. May be authorized to sign documents for the Chair. Maintains security and confidentiality of IRB files. Administration - May assist CSRI Administration with site visits or Audit of the IRB Office. Maintains and updates database accurately and timely. Cooperates with other Research Institute members to achieve use of a common data base and other resources. Participates in the development of IRB Policies and the PHS Assurance. Requires effective work in a group and clear and concise communication. Participates in discussion and from this writes comprehensive copy. Minimum Requirements: Bachelor's degree, or equivalent, plus 3 - 5 years experience in research administration. IRB Experience is preferable. Skill in effectively managing executive committee review processes and of positive interpersonal relations. Ability to gain and refine detailed knowledge of a substantial body of regulatory information. Requires ability to analyze and synthesize complex concepts and transfer into written documents, or independently determine appropriate decisions and how to communicate them in a team environment. Understanding of scientific and medical concepts and terminology is helpful. Skill in working with computer software is required. Ability to motivate self, set priorities, and meet deadlines. In addition must have the ability to communicate clearly and concisely verbally and writing. Knowledge and facility with written English grammar, spelling, and editorial ability required. If interested, send resume to: Philip Sinclair xxxxxx@cshs.org Recruiter Staffing Specialist Cedars-Sinai Medical Center Please refer to Requisition Number: 1990922 12/10/99 ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================