Program Manager, Research Compliance & Quality Assurance
加入一个与你共同的团队。在多护理,你不仅仅是职位名你是一个建立在相互信任,我们的患者和社区上的团队的一部分。在这里属于意味着每天生活我们的使命和价值观。如果你的目的和激情符合我们,你会找到一个地方来成长,做有意义的工作,并在感觉到家乡的社区中建立你所喜欢的职业生涯.FTE: 1.0,转班:日期,时间表:日期位置总结 多护理项目经理,研究合规和质量保证监督临床研究遵守和质量保障跨越多个商务单位。个人将支持主要调查员和临床研究协调员遵守监管;参与审计;开发质量流程;并与诊所管理人员和领导层合作。项目经理将支持预测风险管理,重点放在业务启用和创造价值上。责任:· 在整个组织中支持主调查员 (PI) 和临床研究组合者 (CRC) 对符合 CMS 和 FDA 规则以及 ICH E6 (R3) 好临床实践标准的研究和临床试验进行。· 支持 PIs 和 CRC 和其他研究团队成员保持符合 MultiCare 在临床环境中进行研究的内部政策。·参与所有临床研究审计,支持研究团队并提供组织政策专业知识。·开发和实施以提高质量和确保监管机构对 MultiCARE 内开展的所有临床研究的遵守程序。·与诊所管理人员合作为临床研究人员提供领导力和指导,促进持续改善和职业发展文化。· 解释和集成组织政策到临床研究工作流程中,以确保无的行政和临床运作。· 与领导层和研究管理团队合作分析操作数据来确定可改善领域。要求:· 学士学位需要,最好是在科学或医疗保健相关领域 · 商业,医疗保健管理或相关领域的研究生学位优先 · CHRC (认证卫生保健研究合规)首选 ·熟悉 ICH E6(R2 & R3) 好临床实践指南 · 获得良好的临床实验证 (GCP)
查看英文原文
Join a team that shares your calling
At MultiCare, you’re more than just a job title — you’re part of a team built on trust that cares for each other, our patients and our communities. Belonging here means living our mission and values every day. If your purpose and passions align with ours, you’ll find a place to grow, do meaningful work and build a career you love in a community that feels like home.
FTE: 1.0, Shift: Day, Schedule: Day
Position Summary
The Program Manager, Research Compliance and Quality Assurance at MultiCare oversees clinical research compliance and quality assurance across multiple business units. The individual will support Principal Investigators and Clinical Research Coordinators in regulatory adherence; participates in audits; develops quality processes; and collaborates with clinic managers and leadership. The Program Manager will support predictive risk management with a focus on business enablement and value creation.Responsibilities:
- Supports Principal Investigator (PIs) and Clinical Research Coordinators (CRCs) across the organization in conducting research and clinical trials in compliance with CMS and FDA regulations and ICH E6 (R3) Good Clinical Practice standards.
- Supports PIs and CRCs and other research team members in remaining compliant with internal MultiCare policies on conducting research in the clinical environment.
- Participates in all clinical research audits, supporting the research team and providing organizational policy expertise.
- Develops and implements processes to enhance quality and assure compliance with regulatory agencies for all clinical research performed within MultiCare.
- Collaborates with clinic managers to provide leadership and guidance to clinical research staff, fostering a culture of continuous improvement and professional development.
- Interprets and integrates organizational policies into clinical research workflows to ensure seamless administrative and clinical operations.
- Partners with leadership and Research Administration team to analyze operational data to identify areas for improvement.
Requirements:
- Bachelor’s degree is required, preferably in a science or healthcare-related field
- Graduate degree in business, healthcare management or related field preferred
- CHRC (Certified in Healthcare Research Compliance) preferred
- Familiarity with ICH E6(R2 & R3) Guidelines for Good Clinical Practice
- Good Clinical Practice (GCP) certification required or obtained within 6 months of date of hire
- Minimum of six (6) years of experience in a clinical research environment, with emphasis on regulatory compliance and/or clinical conduct
- Three (3) years of experience in a managerial or supervisory capacity preferred
Why MultiCare?
Rooted in the local community
Partnering with patients, families and neighbors across the Pacific Northwest for more than 140 years.
Growth and education
Competitive tuition assistance, award-winning residencies, fellowships and career development to invest in you.
Well-being and support
Generous PTO, Code Lavender and Employee Assistance Programs to help you maintain balance and feel cared in your work and life.
Living our values
Respect, integrity, kindness and collaboration guide how we care for patients, communities and each other.
Belonging for all
Resource Groups and outreach programs help ensure every team member feels safe, seen, heard and valued.
Pacific Northwest lifestyle
Work and live where natural beauty, adventure and strong community connections are part of everyday life.
Pay and Benefit Expectations
We provide a comprehensive benefits package, including competitive salary, medical, dental and retirement benefits and paid time off. As required by various pay transparency laws, we share a competitive range of compensation for candidates hired into each position. The pay scale is $108,680.00 - $156,353.60 USD. However, pay is influenced by factors specific to applicants, including but not limited to: skill set, level of experience, and certification(s) and/or education. If this position is associated with a union contract, pay will be reflective of the appropriate step on the pay scale to which the applicant’s years of experience align.Associated benefit information can be viewed here.
Originally posted on Himalayas