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Clinical Regulatory Coordinator

Overview

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Ad number:#460468691
Contact:Global Channel Management, Inc.
City:Cambridge, MA
Zip:02138
Compensation:$51/HR

Description

https://www.globalchannelmanagement.com/jobopenings

jobs@globalchannelmanagement.com

Clinical Regulatory Coordinator needs 1-4 years of clinical research experience in academic and/or industry settings

Clinical Regulatory Coordinator requires:

  • oncology experience strongly
  • Bachelor’s degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field
  • Working knowledge of ICH GCP and FDA guidelines
  • Knowledge of and direct experience with Trial Master Files.
  • Prior regulatory operations experience desirable.
  • Fundamental knowledge of conduct of clinical trials is preferred.
  • Strong focus on teamwork, attention to detail, excellent organizational skills. 
  • Must have ability to prioritize, and the ability to work in a multi-task environment.
  • Must be able to work independently.
  • Must maintain confidentiality of information, demonstrate good decision-making and judgment.
  • eTMF (e.g. Veeva) experience preferred.
  •  

Clinical Regulatory Coordinator duties:

  • Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory authorities.
  • Maintain Trial Master Files.
  • Act as a liaison between the Site IRBs and Clinical team to resolve regulatory queries and concerns.
  • Prepare and assist in submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews

 

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