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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Michael Liuzza

Senior Recruiter

As a Senior Recruiter, Michael Liuzza brings almost a decade of sourcing and hiring experience to the JVT team. In his current role, Michael is responsible for full lifecycle recruiting, partnering with JVT's Contract Recruiting Team to match superior available talent with career building opportunities.

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