About the Role
The Clinical Research Regulatory Coordinator I is responsible for preparing, organizing, and maintaining regulatory documents for clinical research studies. This position ensures adherence to Good Clinical Practice (GCP) guidelines, institutional policies, and federal regulations throughout the lifecycle of research protocols.
Responsibilities
- Prepare and submit regulatory documents for initial review and ongoing approval of clinical studies
- Coordinate communication with institutional review boards and regulatory agencies
- Maintain up-to-date regulatory binders for active clinical trials
- Ensure compliance with federal, institutional, and sponsor-specific requirements
- Track submission deadlines and coordinate responses to regulatory inquiries
- Assist in the development and revision of informed consent forms
- Support audit readiness by organizing and archiving study records
- Verify accuracy and completeness of regulatory documentation
- Facilitate timely activation of research protocols
- Collaborate with research teams to ensure adherence to approved protocols
- Monitor changes in regulatory requirements and implement updates
- Manage regulatory aspects of multi-site study coordination
- Provide regulatory training to research staff as needed
- Coordinate annual renewals and continuing reviews for ongoing studies
- Assist in preparing for internal and external audits
- Maintain regulatory tracking systems and databases
- Ensure proper documentation of protocol deviations
- Support investigator-initiated trial submissions
- Work with sponsors and contract research organizations on regulatory deliverables
- Ensure proper handling and storage of regulatory materials
- Participate in process improvement initiatives for regulatory operations
- Assist in onboarding new research team members on regulatory procedures
- Coordinate regulatory closeout activities for completed studies
- Maintain confidentiality of sensitive research and participant data
- Support quality assurance and quality control activities
Compensation
Competitive salary and comprehensive benefits package including health insurance, retirement plans, and paid time off
Work Arrangement
Onsite with potential for hybrid work arrangements based on operational needs
Team
Part of a multidisciplinary research team dedicated to advancing clinical studies in a large academic health system
About the Department
This position is located within a leading psychiatric research institution affiliated with a major academic medical center, focused on advancing understanding and treatment of mental health disorders through innovative clinical studies.
Equal Opportunity Employer
We are committed to diversity, equity, and inclusion in our workforce and provide equal employment opportunities to all qualified applicants regardless of race, color, religion, sex, national origin, sexual orientation, age, disability, or protected veteran status.
Not typically available for this position
