| Protocol Specialist, IRB -- Worcester, MA |
Author: Michael Centola
Date: 08-03-11 17:03
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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