About IHIAt 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 DoThe 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 auditingReview 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 activitiesOversight of internal investigations and CAPA program where requiredThe OpportunityConduct internal auditing activities to ensure research studies are performed in compliance with sponsor protocols, Good Clinical Practices (GCPs), SOPs, and applicable regulationsDocument 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 consistencyConduct 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 studiesUpdate research staff on new regulatory changes and new guidance documentsParticipate in training of external, non-IHI personnel such as faculty of Partners Physician AcademyMember 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 necessarySupervise 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. RequirementsMinimum 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 requiredValid driver’s license and insured automobile requiredAll 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 reportsKnowledge of confidentiality requirements related to patient informationSubject matter expertise (as demonstrated by SOCRA or ACRP certification) and understanding of audit/inspection processesKnowledge of GCP auditingKnowledge of FDA regulations regarding clinical research, ICH GCP, EMA, MHRA guidelines and applicable international regulationsAdditional Skills Requirements: Strong technology skills; proficiency in Microsoft Applications, ability to learn and effectively utilize various eCRF systems and an Electronic Medical Record system, and an inclination to adopt technology to maximize efficiencyDemonstrated analytical and problem solving skills Competency in relaying findings in a productive educational manner to ensure staff understanding and ongoing compliance High level of attention to detail required BenefitsWhy 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 IHI research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 40 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more. Innovative Hematology Inc. is an Equal Opportunity Employer.
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/inspection processes
- Knowledge of GCP auditing
- Knowledge of FDA regulations regarding clinical research, ICH GCP, EMA, MHRA guidelines and applicable international regulations
Additional Skills Requirements:
- Strong technology skills; proficiency in Microsoft Applications, ability to learn and effectively utilize various eCRF systems and an Electronic Medical Record system, and an inclination to adopt technology to maximize efficiency
- Demonstrated analytical and problem solving skills
- Competency in relaying findings in a productive educational manner to ensure staff understanding and ongoing compliance
- High level of attention to detail 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 IHI research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 40 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more.
Innovative Hematology Inc. is an Equal Opportunity Employer.
