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About IHI At the Innovative Hematology (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 Research Quality Assurance (QA) Manager is responsible for: Creation, implementation, and maintenance of a clinical research quality management system in conjunction with IHI CEO and Medical Director and IHI Chief Clinical Officer Evaluations of existing studies through auditing Review and oversight 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 review of other functional area SOPs relating to clinical research activities Oversight of internal investigations and CAPA program where required 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 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. 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 Partners 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 Supervise a small independent team of Research staff (Research Data Manager, Research Education Coordinator, or other staff as assigned) This position is designed as a hybrid role, splitting time between our Center in Indianapolis, IN and home. Minimum travel expectations include quarterly visits on-site for those not located in the Indianapolis metro area, or as otherwise requested for Center-specific or Research-specific needs. Minimal travel to applicable conferences or meetings may be required. Requirements Minimum of Bachelor's degree in related field required. Master's degree in related field preferred. Minimum of 5 years of experience in clinical research required. Good Clinical Practice (GCP) QA leadership experience preferred. SOCRA or ACRP certification required Valid driver’s license and insured automobile required All IHI employees are expected to enable multi-factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role.  Additional Knowledge Requirements: Knowledge of research methods and procedures sufficient to review data and prepare reports Knowledge of confidentiality requirements related to patient information Subject matter expertise (as demonstrated by SOCRA or ACRP certification) and understanding of audit/inspect