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Regulatory Affairs Assistant (START Midwest)

Cancer & Hematology Centers of Western Michigan
Grand Rapids, MI Full Time
POSTED ON 4/15/2024
Regulatory Affairs Assistant- START Midwest
General Summary
Under general supervision of the Regulatory Affairs Specialist, this position is responsible for various administrative duties in the regulatory department.
Job Requirements
Education: High School Diploma
Experience: At least two years’ experience in administrative setting. Proficient working knowledge of Microsoft Word. Strong organizational skills and a sense of timeliness in completing projects; detail-oriented. Good spelling, composition and proofreading skills (medical terminology a plus, but not required). Must be able to complete tasks with minimal supervision and have ability to understand instructions, compose reports and correspondence.

Primary Duties and Responsibilities (Essential Functions)
  • Stamp and distribute all incoming departmental mail
  • Prepare file folders for all new studies
  • Maintain regulatory files (paper and electronic), including IRB submissions and correspondence
  • Review, process and/or submit IND Safety reports, SUSAR reports, and other interim safety reports to the IRB
  • Process and/or submit SAE reports to the IRB
  • Grant and maintain monitor access to SharePoint
  • Oversee monitor visits (ensure files are up to date, print quality assurance comment cards for each study, be available to answer questions from monitors, etc)
  • Review, obtain signatures (if needed), and file incoming monitor letters
  • Obtain signatures on Delegation of Authority logs (or similar logs) from appropriate personnel
  • Maintain and request updated laboratory documents (CLIAs, CAPs, Director CVs/MLs, normal ranges) for core laboratories
  • Review incoming lab reports for outside laboratories and request laboratory documents
  • Share responsibility with other Regulatory Affairs staff to note changes in FileMaker database (personnel, study monitors, etc)
  • Perform other duties as assigned
Work Environment
Able to see clearly in an environment which is equipped with typical lighting. Able to perform manual tasks that require the use of fine muscle motor skills. Able to stand and or sit for prolonged periods. Able to access, input and retrieve information from computer. Very fast-paced and ever changing office environment.

Salary.com Estimation for Regulatory Affairs Assistant (START Midwest) in Grand Rapids, MI
$66,916 to $89,135
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