| Administrative Analyst/Specialist Exempt I -- San Diego, CA |
Author: Amy McDaniel
Date: 06-03-10 18:34
San Diego State University
Job Title: Administrative Analyst/Specialist Exempt I, Graduate and Research Affairs
Job ID: 1877
Location: San Diego Main Campus
Full/Part Time: Full-Time
Regular/Temporary: Temporary
POSITION INFORMATION
Full-time, temporary position anticipated to end on or before December 31, 2010, with the possibility for reappointment.
Employees who are required to operate motorized vehicles and/or use their personal vehicle more than once a month on University business are required to take a mandatory Defensive Driving course and enroll in the DMV Employer Pull Notice (EPN) Program.
Salary Range: $3,845 Monthly.
This position is subject to a mandatory California State University furlough program, which requires two unpaid furlough days per month beginning July 1, 2009 through June 30, 2010. The above salary does not reflect the impact of this program.
RESPONSIBILITIES
Responsible for implementation and management of policies and procedures associated with SDSU affiliated human subject research, consistent with federal and state regulations and University policies. Provide guidance to investigators in research protocol development, conduct reviews of protocol applications to identify problems and issues that may prohibit a complete review or compromise regulatory compliance, compose clear and concise written correspondence, maintain records in accordance with regulations and generate reports detailing Human Research Protection Program (HRPP) activities. Review protocol modifications, continuations and adverse event reports and oversee preparation of agenda materials and minutes of convened committee meetings in accordance with federal requirements. Work with investigators throughout the application process as a resource of ethical research practices and federal, state and institutional policy. Develop methods to enhance communication with investigators, administrators and staff and serves as a liaison to technical staff for purposes related to the Institutional Review Board (IRB) information and web-based systems.
KNOWLEDGE, SKILLS & ABILITIES
Comprehensive knowledge of federal, state, and local regulations and policies governing human subject research including: the Department of Health and Human Services Office of Human Research Program regulations, Food and Drug Administration regulations for the use of investigational drugs, biologics and devices, California law on human experimentation, and university policy regarding human subjects research. Ability to gain and refine detailed knowledge of a substantial body of regulatory information, analyze and synthesize complex concepts, and communicate this information effectively in the compliance monitoring and education process. Ability to develop, monitor and maintain a comprehensive training program on human subjects protections to ensure that relevant and accurate information is accessible to students, faculty and staff. Ability to foster open communications within the institution to enhance ethical and responsible research practices specific to human subject protections.
EXPERIENCE AND EDUCATION
Bachelor's degree and at least two years of related experience in an academic environment.
SPECIALIZED REQUIREMENTS
At least two years experience in regulatory compliance at an academic institution with a focus on human subjects protection. Experience in development and implementation of education/training targeting university students and faculty. Excellent organizational, analytic and administrative skills. Proficiency in understanding and applying complex federal, state and local regulations and developing institutional policy that support regulatory compliance and facilitate research. Exceptional interpersonal skills with colleagues, students, faculty and staff. Excellent oral and written communication skills. Experience using Microsoft Office Suite.
SPECIALIZED SKILLS
Advanced degree preferred. Eligible for IRB Professional Certification (CIP) preferred.
ONLINE AT: www.sdsu.edu or
https://cmsweb.cms.sdsu.edu/psp/HSDPRDF/EMPLOYEE/HRMS/c/HRS_HRAM.HRS_CE.GBL?Page=HRS_CE_HM_PRE&Action=A&SiteId=1 .
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