Oncology Research Regulatory Coodinator

Trinity HealthHartford, CT
Hybrid

About The Position

The Oncology Research Regulatory Coordinator (RC) reports to the Oncology Clinical Research Manager and is responsible for coordinating regulatory activities for clinical research studies. This role supports protocol submissions, regulatory document preparation, and maintenance of study records to ensure compliance with Trinity Health Of New England policies, federal regulations, and ICH/GCP guidelines. This is a hybrid position requiring a combination of remote and onsite work based on departmental and organizational needs, as determined by the Clinical Research Manager.

Requirements

  • Trinity Health Of New England policies
  • Federal regulations
  • ICH/GCP guidelines

Responsibilities

  • Coordinating regulatory activities for clinical research studies.
  • Supporting protocol submissions.
  • Preparing regulatory documents.
  • Maintaining study records to ensure compliance with Trinity Health Of New England policies, federal regulations, and ICH/GCP guidelines.
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