Oncology Research Regulatory Specialist — Hybrid

Trinity Health Of New England; Hartford (CT); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Trinity Health Of New England is seeking an Oncology Research Regulatory Coordinator to manage regulatory activities for clinical studies, including protocol submissions, regulatory document preparation, and study record maintenance to ensure compliance with policies, federal regulations, and ICH/GCP guidelines.

This hybrid position requires a mix of remote and onsite work as determined by the Clinical Research Manager and department needs, with day shift expectations for full-time employment.

Qualifications

• Experience coordinating regulatory or clinical trial documentation.
• Knowledge of FDA/ICH-GCP guidelines preferred.

Responsibilities

• Coordinate regulatory submissions and maintenance of study records to ensure compliance.
• Support protocol amendments and regulatory updates across studies.

Job description

Trinity Health Of New England is seeking an Oncology Research Regulatory Coordinator to manage regulatory activities for clinical studies, including protocol submissions, regulatory document preparation, and study record maintenance to ensure compliance with policies, federal regulations, and ICH/GCP guidelines.

This hybrid position requires a mix of remote and onsite work as determined by the Clinical Research Manager and department needs, with day shift expectations for full-time employment.