| Assistant Manager, IRB -- Worcester, MA |
Author: Michael Centola
Date: 08-03-11 17:01
GENERAL SUMMARY OF POSITION: Under the general direction of the IRB Manager, the Asst. Manager, Institutional Review Board (IRB) provides guidance and training for the office staff in the day-to-day work of the Human Subjects Office, especially as it relates to institutional protocols and regulatory compliance. The Asst. Manager, IRB is responsible for ensuring adherence to policies and procedures related to human subject protections, improving IRB practices, compliance and operational efficiencies for the review of over 900 active human research protocols.
JOB DESCRIPTION:
MAJOR RESPONSIBILITIES: Ensure regulatory compliance in IRB office through attention to workflow, metrics and deliverables on all review and approval processes Develop and conduct ongoing education and training program in IRB processes, GCPs and responsible conduct of research as noted in federal guidance documents (FDA,OHRP,OCR) for office staff, IRB committee members and research community Review of all protocols, including requests for special handling, in the absence of the IRB Manager Determination of exemption requests, assignment of expedited protocol reviews and routing of protocols for full IRB review Provide day-to-day guidance to professional and administrative IRB staff Assist in reviewing and updating of current IRB procedures; assist in updating and creating Standard Operating Procedures (SOPs) to ensure accurate information and compliance with applicable regulations and guidance in collaboration with Manager of IRB and IRB executive committee Attendance at all IRB meetings; transcribe minutes and abstract committee concerns for each protocol for investigator resolution , in the absence of the IRB Manager Review all adverse event reports and determine routing to physician Chair of IRB and further action as warranted, in the absence of the IRB Manager Draft agenda and facilitate meetings of the executive committee of the IRB Facilitate resolution of daily queries on IRB policy by phone or email Consultation with investigators and research staff as needed Monitor for violations of regulations and handle them in accordance with federal guidelines In collaboration with the IRB Manager and AVP identify and resolve ethical dilemmas related to the conduct of clinical research Perform other duties as required
MINIMUM QUALIFICATIONS: Bachelors degree in a health care field, or equivalent 5 years experience in an academic human subjects research environment High level communication skills, both oral and written, necessary to interact with Chair of the IRB Committee and its members, investigators, study staff, research administrators and auditors Ability to perform with minimal guidance within established policies and procedures Working knowledge of policies, procedures, and requirements of federal and private granting agencies, as well as legal, business and academic requirements Experience with supervision in an active research office setting
SUPERVISION EXERCISED: Functional supervision of professional and administrative IRB staff
UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL The University of Massachusetts Medical School, one of the fastest growing academic health centers in the country, has built a reputation as a world-class research institution, consistently producing noteworthy advances in clinical and basic research. UMass Memorial is the clinical partner of UMMS and the largest health care system in Central and Western Massachusetts. As a research institution, UMMS attracts nearly $200 million annually in funding from government agencies, private groups and philanthropic organizations. Faculty members are nationally recognized authorities in areas ranging from cancer to diabetes to genetics and are regularly honored for their work. In 2006, Professor Craig Mello, PhD, was a co-recipient of the Nobel Prize in Medicine for uncovering the mechanisms of the gene-silencing process, RNAi interference.
As an equal opportunity and affirmative action employer, UMMS recognizes the power of a diverse community and encourages applications from individuals with varied experiences, perspectives and backgrounds.
To apply visit
http://www.umassmed.edu/hr/jobs/UMMSJobs.aspx?ID=wsp
and search by Requisition Number: 20943
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