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Posted Job Title
Role Title: Associate Director, Radiology IND/IDE Support Office
Job Profile Title
Associate Director D, Research
Job Description Summary
The Associate Director, Radiology IND/IDE Support Office leads the oversight of IND and IDE studies, with a strong emphasis on clinical research monitoring, risk-based monitoring, and regulatory compliance. This role directs the daily operations of the IND/IDE Support Office, serves as the primary FDA liaison, and oversees regulatory submissions, including IND/IDE applications, amendments, annual reports, safety reports, and associated FDA forms.
The position is responsible for developing and implementing risk-based monitoring plans, overseeing monitoring visits/audits, reviewing source documentation and study data, identifying compliance risks, and ensuring timely implementation of corrective and preventive actions (CAPAs).
The Associate Director ensures protocol compliance, subject safety, data integrity, and inspection readiness across all active and pending IND/IDE studies. Leads the preparation, review, and submission of FDA regulatory documents, including Forms FDA 1571 and 1572, IND and IDE applications, protocol amendments, annual reports, safety reports, and other required regulatory filings.
Additionally, the Associate Director leads quality assurance and compliance initiatives, prepares research teams for FDA inspections and audits, and ensures adherence to FDA regulations, GCP, institutional policies, and SOPs.
The role supervises regulatory and monitoring staff and collaborates closely with investigators, faculty, and institutional leadership to support efficient, compliant, and high-quality clinical research operations.
Core Competencies: Clinical Research Monitoring, Risk-Based Monitoring, IND/IDE Regulatory Oversight, Research Compliance, Quality Assurance, Inspection Readiness, FDA Regulations, GCP, CAPA Management, Data Integrity, Clinical Research Operations, Staff Leadership, and Strategic Operations Management
Job Description
Job Responsibilities
Key responsibilities include:
1 . Oversight of regulatory support for investigational drugs and devices- Oversees FDA regulatory, safety, and compliance activities for IND/IDE studies.
2 . Clinical Research Monitoring and Compliance- Leads monitoring oversight to ensure compliance, data integrity, and participant safety to FDA and institutional guidelines.
3. Leadership and Staff Management- Supervise Regulatory Staff (Team of 4. Cross-Functional Collaboration- Lead Cross Functional Teams and serve as a subject matter expert, involving…