| Protocol Specialist -- Worcester, MA |
Author: Beth McNutt
Date: 04-29-08 13:52
Protocol Specialist - University of Massachusetts Medical School, Worcester, MA
(08-0523)
GENERAL SUMMARY OF POSITION:
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.
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 UMMS:
At the University of Massachusetts Medical School, we take seriously our mission to serve the people of Massachusetts. We do this by achieving national distinction in health sciences education, research and public service. In the area of research, UMMS has achieved world-class status. Research is conducted in the laboratory, ambulatory clinic and at the bedside, contributing significantly to medical science and to the state's economy, as well as enhancing our ability to attract outstanding faculty members for all three schools. Extramural research funding totals over $174 million, placing UMMS in the top 40 among the nation's medical schools in funding.
Benefits at UMMS:
We offer highly competitive salaries based on experience; an excellent benefit package including generous time-off policies, 13 paid holidays, paid continuing education, health, dental and vision coverage.
To apply:
Apply online using this address:https://www.jobs-umassmed.org/umm/jobboard/JobDetails.aspx?__ID=*822A47213D452043
Resumes may also be mailed or faxed to: Human Resources, University of Massachusetts Medical School, 419 Belmont Street, Worcester, MA 01604, 508-856-2390. Please reference code 08-0523.
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Author |
Date |
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Protocol Specialist -- Worcester, MA new |
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Beth McNutt |
04-29-08 13:52 |
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