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Clinical Regulatory Coordinator

Location: Cambridge, Massachusetts Salary: US$48 - US$52 per hour + negotiable based on experience
Sector: Pharma & Biotech Type: Contract

Clinical Regulatory Coordinator

A global pharmaceutical corporation specializing in Oncology therapies is seeking to hire a Clinical Regulatory Coordinator for a 6-month contract. This individual will be working closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory authorities.

The Clinical Regulatory Coordinator will be responsible for: 1) liaising between the Site IRBs and Clinical team to resolve regulatory queries and concerns. 2) Prepare and assist in submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews. 3) Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance, and troubleshoots processes and procedures when issues are identified.4) Maintenance of Trial Master Files (TMF & eTMF).

Duration: 6-month contract

Location: Cambridge, Massachusetts (office-based)

Compensation: $48-52 per hour

Requirements

  • 1-4 years of clinical research experience in academic and/or industry settings.
  • Education: Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field.
  • Oncology experience strongly preferred.
  • Prior knowledge direct experience with Trial Master File (TMF) and eTMF (ie.Veeva Vault) is highly preferred.
  • Experience Electronic Data Capture (EDC) such as Inform for clinical trials.
  • Demonstrate a working knowledge of internal SOP's, FDA/lCH guidelines to GCP's and regulatory compliance.

Sthree US is acting as an Employment Business in relation to this vacancy.