Document Specialist - Sarah Cannon Research Institute - Nashville, TN
Sarah Cannon Research Institute -Nashville - Nashville, TN

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GENERAL SUMMARY OF DUTIES - Primary responsibilities include processing, tracking and maintenance of regulatory documentation. This position will work closely with the regulatory affairs specialists and project teamsto ensure compliance while meeting strict deadlines.

  • Review, process, and electronically track study-specific regulatory documents, including IRB approvals, credentials, and correspondence;
  • Assist in the maintenance of document tracking systems and electronic files as necessary
  • Work with regulatory affairs team and project teams to achieve goals for quality assurance and compliance; check for expired credentials and approvals on a routine basis
  • Ensures all regulatory documentation is compliant with GCP and local Standard Operating Procedures (SOPs) for format and content.
  • Maintain updated credentials and other critical documentation ensuring compliance as assigned.
  • Assist with review of informed consent forms
  • Assist teams in preparation for internal and external audits; conduct quality checks of essential documents as needed
  • Assist any internal or external audit team with any regulatory related issues.
  • Participate in educational activities and programs.
  • Maintain strictest confidentiality.
  • Perform related work as required.
KNOWLEDGE, SKILLS, & ABILITIES - This position requires the following minimal requirements:

  • Ability to work with within deadlines.
  • Attention to detail
  • Strong interpersonal, communication, and organizational skills a must.
  • Working knowledge of MS Office products including Outlook, Word, and Excel.
  • Knowledge of medical and clinical research terminology is preferred.


  • High school diploma or GED is required.
  • Associate's degree in science related field preferred or combination of equivalent education and experience.

  • 6 months experience in healthcare, research or other science or regulated field or equivalent of education and experience preferred.
  • Or equivalent experience