IRB Protocol Specialist

Location
Worcester, Worcester County
Posted
Apr 16, 2014

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 and 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

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ADDITIONAL RESPONSIBILITIES (IRB):  


  • 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.

 

REQUIRED QUALIFICATIONS: 

 

  • Bachelor’s degree and three years of experience or equivalent - with at least two 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


UMass Medical School is committed to being an equal opportunity and affirmative action employer and recognizes the power of a diverse community. We encourage applications from protected veterans, individuals with disabilities and those with varied experiences, perspectives and backgrounds to consider UMass Medical School as their employer of choice.

 


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