What You Will Do The Director of Quality Assurance is responsible for:
- Oversight and continuous improvement of a clinical research quality management system in conjunction with IHI CEO and Medical Director, IHI Chief Clinical Officer, and the Chief Research Officer;
- Evaluations of existing studies through auditing;
- Development of training programs for new and existing research staff in collaboration with Research Education Coordinator;
- Ongoing maintenance and development of QA Standard Operating Procedures (SOPs) and Work Instructions (WIs) and review of other functional area SOPs relating to clinical research activities; and
- Oversight of internal investigations and CAPA program.
The Opportunity- Conduct internal auditing activities to ensure research studies are performed in compliance with sponsor protocols, Good Clinical Practices (GCPs), SOPs, and applicable regulations.
- Document and report on audits. Create/produce audit certificates. As needed, review audit reports with applicable team members.
- Create, update, and maintain an annual audit schedule and review with individual team members.
- Develop and/or review standardized operational procedures (SOP's) and workflows for research related topics ensuring quality through consistency.
- Conduct internal investigations developing Corrective and Preventive Action (CAPA) plans as needed. CAPA trends will be reviewed with Chief Clinical Officer or designees quarterly.
- Prepare and assist in follow-up for FDA Inspections. Be available to host the inspection if requested.
- Develop training program for research staff (physicians, nurse practitioners, physician assistants, research nurses and study coordinators).
- Conduct advanced training for physicians and APPs interested in conducting research at IHI. Serve as mentor and advisor, reviewing study documents including IIS protocols.
- Conduct monthly topic specific QA presentations for all staff participating in research studies.
- Update research staff on new regulatory changes and new guidance documents.
- Participate in training of external, non-IHI personnel such as faculty of Partner's Physician Academy.
- Member of Research Leadership Team. Participate in new study selection process, interviewing/hiring of new staff, discussing and resolving research related issues or concerns.
- Serve as research regulatory advisor for the research department for individual staff members or as a member of a variety of small discussion groups or committees where a research regulatory perspective is necessary.
- Able to supervise a small independent team of Research staff
- Perform other related duties as assigned.
Requirements- Minimum Bachelor's degree in related field. Preferred MS degree or higher.
- Minimum 12 years of clinical research experience with at least 5 years in GCP quality assurance leadership position
- Valid driver's license and insured automobile required
This is a remote position with quarterly visits to IHI or as otherwise needed for on-site training or Center-specific or Research-specific needs. Travel to applicable conferences or meetings may be required.
Benefits 
