Director of Quality Assurance in Clinical Research
New
I
Innovative Hematology, Inc.Clinical Research
Remote, with quarterly visits to IHI in Indianapolis, IndianaFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- Minimum 12 years of clinical research experience with at least 5 years in GCP quality assurance leadership position
- Required Skills
- GCPQuality Assurance
Requirements
- Minimum 12 years of clinical research experience.
- Minimum 5 years of experience in a GCP quality assurance leadership position.
- Minimum Bachelor’s degree in a related field (Master’s degree preferred).
- Expertise in Good Clinical Practice (GCP) guidelines.
- Experience conducting internal audits and developing CAPA plans.
- Experience managing SOPs and regulatory documentation.
- Ability to develop and deliver staff training programs.
- Experience preparing for and managing FDA inspections.
- Valid driver’s license and insured automobile.
- Ability to travel for quarterly visits to Indianapolis, conferences, and meetings.
Responsibilities
- Oversee and continuously improve the clinical research quality management system in partnership with senior clinical and research leadership.
- Perform internal audits to ensure compliance with sponsor protocols, GCP, SOPs, and regulations.
- Develop, update, and maintain SOPs and workflows to ensure operational consistency.
- Manage internal investigations and lead the Corrective and Preventive Action (CAPA) program.
- Prepare for and assist with FDA inspections, including hosting inspections when required.
- Design and conduct training programs for physicians, APPs, and research coordinators.
- Serve as a member of the Research Leadership Team to assist with study selection and staff hiring.
- Provide research regulatory advice and mentorship to staff across various committees.
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