Clinical Operations Regulatory Specialist

Reporting Relationship: Sr Clinical Project Manager

Responsibilities

  • Responsible for overall quality, maintenance and completeness of Trial Master Files
  • Identify trends or quality concerns and oversee resolution of any issues
  • Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements
  • Act as a liaison between the Site IRBs and Clinical team to resolve queries and concerns
  • Prepare and assist in submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews
  • Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings

Qualifications

  • 1-4 years of clinical research experience in academic and/or industry settings; oncology experience strongly preferred
  • Demonstrate a working knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2)
  • Knowledge of, and direct experience with Trial Master Files, with experience with electronic TMF systems is preferred
  • Fundamental knowledge of the 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 and professionally
  • Bachelor’s degree or higher in life sciences, health sciences, nursing, pharmacy, or related field

Job Location: Cambridge, MA

Please send resumes to talentacquisition@bostonbiomedical.com