| Senior Research Compliance Specialist -- San Francisco, CA |
Author: Jon Merz
Date: 08-26-08 20:23
Senior Research Compliance Specialist Clinical Research Office
NCIRE, the Veterans Health Research Institute is a research institute working in conjunction with the San Francisco Veterans Affairs Medical Center. NCIRE has some of the countrys most renowned MD and PhD scientists working in partnership with the University of California San Francisco (UCSF) and the SFVAMC to integrate research interests with the needs of veterans. Medical research is conducted in such diverse areas as aging, cardiovascular disease, neurodegenerative diseases, and cancer.
NCIRE has a full-time opportunity for a Senior Research Compliance Specialist to be responsible for providing support, coordination and administration human subjects research compliance for all research involving human subjects, human tissue or human subjects data to be undertaken at the SFVAMC.
Essential Duties:
Acts as lead in organizing process improvement meetings and ensures follow through of new process changes.
Attends and coordinates all Clinical Research Sub Committee meetings
Oversees review process and tracks applications to completion for all human subjects applications
Reviews minor and administrative modifications consults with deputy ACOS as required
Provide guidance and assistance for new PIs and or new assistants to PIs on protocol.
Supervise Research Compliance Specialists and other support 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 committee review and/or final approval;
Discusses issues with the Human Research Compliance Officer or Deputy ACOS for Clinical Research as needed;
Provides guidance on and answers questions about administrative and technical matters regarding the applications (no scientific or ethical 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 Human Research Compliance Officer or Deputy ACOS for Clinical Research as needed.
Review applications for HIPAA compliance and identify issues for subcommittee action;
Work with Human Research Compliance Officer or Deputy ACOS for Clinical Research to facilitate urgent reviews;
Cooperate with other members of the Clinical Research Office to ensure deadlines for meetings and internal time-to-completion targets are met;
Identifies issues that should be included in Clinical Research Subcommittee letters to investigators;
Communicate progress, problems and ideas to improve systems to the Human Research Compliance Officer;
Monitors and tracks compliance of research protocols for new and on-going projects;
Reviews and maintains documentation of annual education and credentialing requirements for all persons engaged in human subjects research at the SFVAMC (regardless of employer/salary source, if any);
Liaison to UCSF Committees on Human Research;
Participates in local and national training opportunities (such as PRIM&R, and AAHRPP conferences);
Performs other related duties as assigned
Requirements:
Minimum of 5 years experience in human subjects protection;
BA/BS or equivalent number of years experience, MA preferred;
IRB certification preferred
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;
Experience with MS Office (Word, Excel, Access and Outlook)
Ability to write and update operating procedures in response to the ever changing regulatory environment.
NCIRE offers a competitive compensation and generous benefits package, a stable, exciting environment and a wonderful work/life balance.
Please email your resume and cover letter with salary expectation to careers@ncire.org. You must indicate job number 08-260 in the subject line for consideration.
For more information about NCIRE please visit us at www.ncire.org.
NCIRE is an Equal Opportunity Employer
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Author |
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Senior Research Compliance Specialist -- San Francisco, CA new |
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Jon Merz |
08-26-08 20:23 |
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