JVT Advisors

Clinical Regulatory Coordinator

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Location: Cambridge, Massachusetts 02139
Employment Type: Contract

Job Description

Contract length: 6 Months

Responsibilities:

  • Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory authorities
  • 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

Requirements:

  • Bachelor’s degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field
  • 1-4 years of clinical research experience in academic and/or industry settings; oncology experience strongly preferred
  • Must have Trial Mast File experience and Veeva Vault experience preferred
  • Working knowledge of ICH GCP and FDA guidelines
  • Must maintain confidentiality of information, demonstrate good decision-making and judgment

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Jeff Reed

Senior Recruiter

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