Site relationship management role ensuring sustainable trial start - up for assigned sites in clinical drug development at Novartis. Collaborating with global teams and ensuring adherence to clinical operations standards and timelines.
About the role
- Regulatory Coordinator ensuring compliance with research operations and documentation for clinical studies. Collaborating with research teams to maintain regulatory standards and support project objectives.
Responsibilities
- Prepares, facilitates, coordinates, and submits documentation required by federal, state and local regulations and institutional requirements relating to the conduct of research.
- This includes preparation of all submissions to the IRB to assure the protection of human subjects in research; FDA‑required submissions which may include investigator 1572 forms, investigational new drug applications, device submissions such as Emergency use, HDE, Safety Reports, and other documents that may be required by a regulatory agency or the institution.
- Leads the work of Research Assistants on a task-basis if applicable.
- Provides on-the-job training, sets priorities and schedules workflow required to support project objectives.
Requirements
- Bachelor's Degree Preferably in science, healthcare, or other related field --or-- Significant experience in research coordination or regulatory work may be substituted for educational requirements
- 2 years of experience in healthcare, research or clinical setting with regulatory compliance familiarity
Benefits
- Health care benefits (medical, dental, vision)
- 401(k) Savings Plan with employer matching
- Life insurance
- Disability insurance
- Paid time off benefits (paid parental leave, vacations, holidays, health issues)
- Voluntary benefits
- Well-being resources
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