| Protocol Specialist, IRB -- Worcester, MA |
Author: Michael Centola
Date: 10-04-11 16:09
Protocol Specialist, IRB -- Under the general supervision of the IRB Manager,
develops primary role as protocol reviewer and analyst to ensure efficient and
effective research compliance with institutional, state and federal policies
and regulations. The Protocol Specialist takes a proactive role in defining,
evaluating and conducting education and training programs related to IRB
procedures and related regulations and federal guidance
JOB DESCRIPTION:
MAJOR RESPONSIBILITIES:
• Conduct comprehensive and timely review of all new IRB submissions before
Committee assignment, ensuring consistency between submission and related
Protocol
• Perform IRB screening/review of each new submission to ensure completeness
and conformance with established university, federal and state regulations.
Provide instruction and advice to researchers on regulations and preparation
of applications
.
• In collaboration with IRB manager, facilitate ‘expedited review’ process by
communicating with investigators and key
personnel
• Assess educational needs of constituency. Design training programs and
conduct individual and/or group training session. Including training needs of
IRB committee members and conduct update sessions monthly at committee
meetings in collaboration with IRB
Manager
• Serve as consultant to IRB members, investigators and key personnel on
matters related to IRB procedures
.
• Educate and advise investigators and key personnel in response to IRB
submissions; recommend adaptations to ensure adequacy &
completeness
• Follow-up on late and incomplete submissions with investigators and key
personnel
• Organize and prepare IRB meeting agendas and assign appropriate Committee
members as primary reviewers of submissions. Attend all IRB meetings and
prepare minutes in absence of IRB Manager
.
• Monitor, evaluate and update IRB procedures in collaboration with IRB
Manager, Coordinator and office
staff
• Evaluate ‘Continuing Review’ submissions responses determining accuracy and
completeness, request additional material or information in order to address
concerns. Submit to committee for review
.
• Work with IRB Manager, Coordinator and staff to maintain detailed and
complete IRB records, ensuring that all post-approval documents are consistent
with original submission and ongoing
amendments
• Respond to Committee requests and special monitoring requirements as
directed by IRB Chair or IRB
Manager
• Maintain current understanding and knowledge of federal and state
regulations, state and local laws
.
• Perform related duties as required
MINIMUM QUALIFICATIONS:
• Bachelor’s degree and five years of experience or equivalent - with at least
three years experience in human subjects/IRB administration role
preferred
• Knowledge of clinical research and familiarity with medical terminology
• Knowledge of federal regulations pertaining to research
• Ability to educate and conduct training sessions both on individual and
group
level
• Certification as IRB Professional, or equivalent, preferred
• Strong knowledge of Microsoft Word, Access, and Excel.
• Strong knowledge of IRB processes and approval mechanisms included in
ongoing IRB oversight
.
• Requires organizational and interpersonal skills, attention to detail, and
effective oral and written communication skills necessary to interact with all
levels of personnel, both within and outside UMass
Worcester
• Experience in handling complex and confidential material.
• Ability to prioritize, problem solve, and work under pressure in a deadline
oriented
environment
ABOUT UMASS
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: 20939
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