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Clinical Regulatory Coordinator

  • Type Contract
  • Salary competitive
  • Location Cambridge, Massachusetts
  • Sectors Pharma & Biotech

Title: Clinical Regulatory Coordinator

Duration: 6 Month

Location: On site- Cambridge, MA

Compensation: Competitive

Hours Expected: 40 hours per week

Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.

Day to Day Duties/Responsibilities/ Scope of Work:

  • 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.

Qualifications/Requirements:

  • 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.

Education:

  • 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

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