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Regulatory Coordinator
Job Number: 2018-31625
Category: Research
Location: Worcester, MA
Shift: Day
Exempt/Non-Exempt: Exempt
Business Unit: UMass Chan Medical School
Department: School - Office of Research - W407000
Job Type: Full-Time
Salary Grade: 41
Union Code: Non Union Position -W60- Non Unit Professional
Num. Openings: 1
Post Date: Sept. 4, 2018

GENERAL SUMMARY OF POSITION: 

Under the direction of the Manager or designee, the Regulatory Coordinator is responsible to review, assess, and triage all incoming regulatory documents according to the federal and state regulations, as well as institutional policies and procedures. In addition, the Regulatory Coordinator is responsible to facilitate timely communication and coordinate training to investigators and the research community. 

MAJOR RESPONSIBILITIES:

  • Review, assess, and triage the submissions of various initial and continuing review requests according to the state and federal regulations regarding level of review required to fulfill regulations and guidance
  • Develop, implement, and maintain a tracking system for the metrics of performance of processes (initial, continuing review, new information reporting, etc) as well as responses from  investigators and research staff for resolution
  • Resolve concerns and problems as new forms and workflow move to electronic implementation. Elevate concerns to the Manager when appropriate
  • In collaboration with the Protocol Specialists, ensure that delegated pre-review process communications to investigators are handled efficiently.
  • Create an education and training series for forms, processes, and workflow currently in development. Responsible for coordinating department requests for specific trainings. Schedule and coordinate training curriculum and logistics.
  • Act as a liaison for internal and external committees and relevant research support staff
  • As content manager expert for the website, provide support for all web changes and enhancements of information
  • Compile data and documents, assist the Manager in designing reports and creating weekly email updates for the research community, state, or federal agencies
  • Provide support for the Chair and Vice-Chairs as it relates to meeting preparation and application reviews
  • Prepare, maintain and revise research application forms, procedures or instruction manuals; integrate changes as appropriate
  • Perform other duties as required.

REQUIRED QUALIFICATIONS:

  • Bachelor’s degree in a related field, or equivalent experience
  • 3 years of experience in research or regulatory administration or other relevant area
  • Completion of applicable regulatory certification or the ability to complete within designated time from date of employment
  • Experience in handling confidential and sensitive material
  • Effective oral and written communication skills
  • Ability to prioritize, problem-solve and work under pressure in a deadline-driven environment

 

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UMass Chan Medical School was among 23 companies that stood out as 2023 “DEI champions,” according to The Boston Globe.   


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