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Roles and Responsibilities
- Maintain quality control functions and monitoring compliance for research studies.
- Proactively address issues to ensure overall integrity in document management through quality and compliance checks.
- Work collaboratively with key stakeholders within YCC CTO as well as colleagues across the research enterprise.
- This role will oversee assigned service lines(workflow processes) and track regulatory activation milestones and timelines.
- Promote timeline and compliant opening of new studies in additional to providing oversight of clinical trials by actively monitoring approvals, document creation, sponsor relationships and overall study management from a regulatory perspective.
- Supervisor day to day work activities of assigned regulatory staff, including delegation of work units and managing staff workload through communication of job expectations, planning, monitoring and evaluation of work product.
- Provide quality reviews and oversight functions for all IRB submissions and post approvals to ensure regulatory integrity, while evaluating submissions metrics and staff feedback to identify gaps.
- Manager regulatory compliance activities related to quality control, including audit preparation, responses related to regulatory findings, reportable events, corrective actions and special projects related to efficiency and compliance within reg group.