Director of Quality Assurance in Clinical Research

About IHI

At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families.

What You Will Do

 The Director of Quality Assurance is responsible for:  

1. 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; 
2. Evaluations of existing studies through auditing; 
3. Development of training programs for new and existing research staff in collaboration with Research Education Coordinator; 
4. 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 
5. Oversight of internal investigations and CAPA program. 

The Opportunity

1. Conduct internal auditing activities to ensure research studies are performed in compliance with sponsor protocols, Good Clinical Practices (GCPs), SOPs, and applicable regulations.   
2. Document and report on audits. Create/produce audit certificates. As needed, review audit reports w