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:

• 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

Why join our team?

IHI is a not-for-profit program based in Indianapolis and offers a competitive salary and benefit package.

IHI is the only federally designated comprehensive hemophilia program in Indiana and serves the entire state through services available in Indianapolis and at outreach clinics.

IHI is a leader in hemophilia care, education and clinical research and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services.

IHI participates in national and international clinical research, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The IHTC research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more.

Innovative Hematology, Inc. is an Equal Opportunity Employer.