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Job Field: Legal Jobs
Location: San Francisco, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Overview
With minimal supervision the incumbent is
responsible for providing support, coordination
and administration human subjects research
compliance for all human studies research
regulated by
Essential Functions
     Jointly with the HRPP Coordinator GS-301-12
Program Specialist, attends and coordinates all
Clinical Research Workgroup meetings and assists
with development of agendas and minutes
     Oversees review process and tracks
applications to completion for all human subjects
studies
     Provide guidance and assistance to PIs
and/or Clinical Research staff
     Assists with training and supervision of
junior level HRPP staff
     Provides analysis of submissions initial
applications, modifications, correspondence,
renewals or other relevant documents for
conformance with federal regulations, state
statutes, and local policies and procedures
     Communicates with the investigator and/or
their staff to request and explain changes or
additional information required before workgroup
review and/or final approval
     Discusses issues with the supervisor or
research leadership e.g., Clinical Research
Workgroup, Deputy ACOS for Clinical Research,
ACOS/R, RDC Chair as needed
     Provides guidance on and answers questions
about administrative and technical matters
regarding the applications no scientific  review
required
     Compare applications with their
corresponding grant or contract to make sure that
the research plan and study aims are in alignment.
If not, request changes or clarifications from the
study investigator
     Review applications for Conflict of Interest
COI requirements and coordinate with the
supervisor or research leadership as needed
     Work with Human Studies Coordinator or
Clinical Research Workgroup Chair to facilitate
urgent reviews
     Cooperate with other members of the HRPP to
ensure deadlines for meetings and internal time-
to-completion targets are met
     Identifies issues that should be included in
Clinical Research Workgroup feedback to
investigators
     Communicate progress, problems and ideas to
improve systems to the supervisor and research
leadership
     Monitors and tracks regulatory status of
research protocols for new and on-going projects
     Communicates with UCSF Committees on Human
Research
     Participates in local and national training
opportunities such as PRIMR and HRPP
accreditation conferences
     Performs other related duties as assigned
Qualifications
     Minimum of 3 years experience in human
subjects research protection experience with UCSF
IRB applications and procedures and VA HRPP
regulations preferred
     Thorough understanding of privacy and
information data security regulations in human
research
     BA/BS or equivalent number of years of
experience MA/MS preferred
     Human research protection certificate e.g.,
CIP, CHRC or eligible to receive certificate
     Ability to follow and establish operating
procedures and keep excellent records
     Ability to work concurrently on multiple
projects and respond to multiple competing demands
     Knowledge of medical terminology and general
understanding of common clinical procedures
     Superior oral and written communication
skills
     Excellent organizational skills / superb
attention to detail
     Demonstrated ability to work with a wide-
range of personnel
     Database experience preferred
     Experience with MS Office Word, Excel,
Access and Outlook iMedRIS preferred
     Ability to write and update operating
procedures in response to the ever changing
regulatory environment
NCIRE is an Equal Opportunity Employer

KEY REQUIREMENTS:

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None Bachelors degree