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Regulatory Coordinator

Posted: May 20, 2024
Salary:US$25.00 - US$30 per hour
Job type: Contract
Discipline:Life Sciences
Work Location:Hybrid

Job description

  • Maintains research practices using Good Clinical Practice (GCP) guidelines.
  • Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs.
  • Handle confidential material with judgement and discretion
  • E-filing and sorting from DocuSign to Trial folders on G-drive.
  • Reviews ICF completion, to verify documentation completed properly.
  • Releases ICF due to requests from Study Coordinator.
  • Prepares and releases documentation for training for New Amendments, New
  • IB's, Protocol Letters and or clarifications among other training document preparation.
  • Documents research staff and investigators initial participation on trial and releases documents.
  • Tracks and logs pending documents efficiently.
  • Request Certification for new research staff and Investigators.

Education and Experience:

  • Associates Degree or one or more (1+) years experience with regulatory documents.
  • Typing and computer skill/ability including word-processing, use of spreadsheets, e-mail (PC, WORD, EXCEL, POWER POINT).
  • Demonstrated experience with multi-study and multi-site clinical research activities.
  • Demonstrated knowledge and understanding of human research policies, regulations, procedures, and standards as according to HIPAA, IRB, FDA, ICH, and GCP guidelines.
  • Demonstrated knowledge of FDA and Sponsor regulatory requirements.
  • Knowledgeable of FDA and QA audit processes.