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

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