临床项目助理
Clinical Project Associate
这不仅是一份职业，更是一项使命。
我们的员工是成功的基础。加入位于美国的Sarah Cannon Research Institute（SCRI）——麦肯锡公司旗下子公司，你将有机会成为全球最大的基于社区的癌症项目之一的一部分，以推动肿瘤治疗的发展并改善全球癌症患者的结果。我们寻找有使命感的候选人，他们希望在对抗癌症的战斗中取得进展，并每天为被诊断出癌症的患者带来改变。
我们的使命
患有癌症的人——那些努力预防、对抗和战胜癌症的人——是我们每个决策的核心。我们将最创新的医学专家与社区中最热情的护理人员结合在一起，正在改变医疗方式并实现个性化治疗。通过临床卓越和前沿研究，SCRI正在重新定义全球的癌症护理。
作为临床项目助理，你需要确保试验主文件（TMF）设置并维护在“审计就绪”状态；并在研究生命周期内按照良好临床实践、ICH指南、联邦法规和发展创新SOP进行关键文档的收集和审查。你将维护临床试验管理系统和跟踪工具，积极参与跨职能团队以确保项目交付物的完成。
该职位为远程办公，位于美国；不提供搬迁补助和签证担保。
职责包括但不限于：
- 你将设置并上传文件到TMF/eTMF
- 你将在上传/归档到TMF/eTMF之前对文档进行初步质量审查
- 你将与文档专家合作，从研究开始到结束，保持试验主文件（TMF）处于“审计就绪”状态
- 你将协助确认研究人员和研究站点的资格
- 在临床试验的整个生命周期中，你将负责关键文档的分发和收集。积极与临床研究助理和研究站点沟通，解决未决的监管问题
- 你将审查研究文档，确保其为最新、完整和准确
- 其他指派的任务
所需资格：
- 最低高中文凭或同等学历
查看英文原文
It’s More Than a Career, It’s a Mission.
Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.
Our Mission
People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.
As the Clinical Project Associate, you are responsible for ensuring the Trial Master File (TMF) is set-up and maintained in “audit ready” condition; and conduct critical documentation collection and review throughout the lifecycle of the study, in accordance with Good Clinical Practices, ICH Guidelines, Federal Regulations and Development Innovations SOPs. You will maintain clinical trial management systems and tracking tools, actively participating in cross-functional teams to ensure delivery of project deliverables.
This position is remote based in the US; relocation assistance and visa sponsorship are not available.
Duties include and are not limited to:
- You will set-up, document collection/upload of files to the TMF/eTMF
- You will perform initial quality review of documents prior to upload/filing in the TMF/eTMF
- You will partner with document specialist to maintain the Trial Master File (TMF) in “audit ready” condition from study start to completion
- You will assist with confirming the qualifications of investigators and investigative sites throughout the conduct of the clinical trial
- You perform critical document distribution to and collection from the investigative sites throughout the lifecycle of the clinical trial. Proactively liaise with Clinical Research Associate and investigative site to resolve outstanding regulatory issues
- You review study documents to ensure they are current, complete and accurate
- Other duties as assigned
Qualifications needed:
- Minimum High School Diploma or GED
- At least 1 year of clinical research experience required; at least 3 years of clinical research experience preferred.
- Oncology clinical research experience preferred
About Sarah Cannon Research Institute
Sarah Cannon Research Institute (SCRI) is one of the world’s leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI’s research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings.
We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here.
As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
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Originally posted on Himalayas