Oncology Research Regulatory Coodinator

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

Employment Type: Full time Shift: Day Shift

Description: 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.

Our Commitment

Rooted in our Mission and Core Values, we honor the dignity of every person and recognize the unique perspectives, experiences, and talents each colleague brings. By finding common ground and embracing our differences, we grow stronger together and deliver more compassionate, person-centered care. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other status protected by federal, state, or local law.