临床研究质量保证总监
Director of Quality Assurance in Clinical Research
关于IHI
在Innovative Hematology, Inc.（IHI），我们提供一个让罕见血液疾病患者蓬勃发展的未来。我们的专家为出血、凝血及其他血液系统疾病患者及其家庭提供最高质量的综合服务和整体照护。
你将负责
质量保证总监负责：
- 与IHI首席执行官和医学主任、首席临床官及首席研究官合作，监督并持续改进临床研究质量管理体系；
- 通过审计评估现有研究；
- 与研究教育协调员合作，为新老研究员工制定培训计划；
- 持续维护和发展QA标准操作程序（SOP）和工作指令（WIs），并审核与临床研究相关的其他职能领域SOP；
- 监督内部调查和CAPA（纠正和预防措施）项目。
机会
· 进行内部审计活动，确保研究项目符合赞助方协议、良好临床实践（GCP）、SOP及适用法规。
- 记录并报告审计结果。制作/生成审计证书。必要时与相关团队成员审查审计报告。
- 制定、更新并维护年度审计计划，并与各团队成员进行审核。
- 制定和/或审核研究相关主题的标准操作程序（SOP）和流程，确保通过一致性实现质量。
- 进行内部调查，根据需要制定纠正和预防措施（CAPA）计划。CAPA趋势将每季度与首席临床官或其代表进行审核。
- 准备并协助跟进FDA检查。如需，可接受主持检查。
- 为研究员工（医生、护士执业者、医师助理、研究护士和研究协调员）制定培训计划。
- 为有兴趣在IHI开展研究的医生和APP（高级执业注册护士）提供高级培训。担任导师和顾问，审核研究文件，包括IIS协议。
- 为所有参与研究项目的员工进行每月特定主题的质量保证讲座。
- 向研究员工传达新的监管变化和新指导文件。
- 参与对外部非IHI人员的培训，例如合作伙伴医学院的教职员工。
- 研究委员会成员
查看英文原文
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.
Originally posted on Himalayas