临床研究专员II
Clinical Research Associate II
PSI 是一家领先的合同研究组织，在行业内已有 30 多年的历史，为客户提供稳定与创新的完美平衡，也为员工提供这样的环境。我们专注于在多种治疗领域提供高质量且按时的服务。
在 PSI 担任临床研究助理，您将参与多种监查任务，并在不同治疗领域开展临床研究，同时保持行业最高质量标准。
您将：
· 作为项目团队、申办方和研究现场之间的主要沟通渠道
· 与参与研究实施的现场工作人员建立并维护良好的关系
· 准备、执行并报告现场选择、启动、常规监查和结束访问
· 确保受试者招募目标及时制定、传达、记录并达成，同时在现场层面遵循项目时间表
· 确保不良事件和方案/流程偏离信息在试验现场的准确和及时传递
· 执行源数据验证，并跟进现场的数据查询；在现场层面审查和管理研究风险
· 确保所有试验药物（Investigational Product）和临床研究物资在现场的正确处理、使用、责任归属、对账和归还
· 审查关键研究文件，并在现场层面协调研究者现场文件（ISF）/试验主文件（TMF）
· 确保现场层面的质量（数据完整性和合规性）
· 进行现场审计准备访问并解决现场审计发现的问题
· 参与研究现场审计和客户现场访问，根据需要
· 确保项目团队、现场和中心/区域实验室/中心评审员/仓库之间的文件和研究物资流动
· 对现场研究者进行项目特定培训
· 协助准备研究者简报
· 协助现场管理助理在现场层面维护研究特定和公司跟踪系统
· 协助准备监管和伦理委员会提交包的草案
· 协助在现场/国家层面收集 IP-RED 包
· 协助在国家和现场层面审核和对账研究 TMF
- 生命科学相关专业本科/大学学历，或同等教育、培训和经验组合
- 优先考虑位于中部或西海岸地区的候选人
- 必须有 2 年以上独立现场监查经验
- 具有各种类型监查访问的经验
查看英文原文
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
PSI’s business is about conducting clinical research of novel medications. We work at the interface of R&D, pharmaceutical industry and healthcare science and provide services to big and mid-sized pharmaceutical companies. We help our clients to generate data about safety and efficacy of medications and bring the best ones to market. By conducting global clinical research trials, PSI makes cutting-edge treatment available in drugstores all over the world and helps patients with serious medical conditions to improve or even save their life. Help us to make sure that PSI medical and business documents are clear to patients, physicians, regulatory authorities, and clients.
We offer an inspiring story of the company that has grown organically from a handful of countries to global presence. PSI is a mature company with standards and practices, but we do not stand still. Every day, there is a figurative Everest to climb, and you will not get bored here.
We’re searching for a knowledgeable, team-oriented CRA II to manage the clinical aspects of full-service global projects in Australia. As a CRA II at PSI, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects’ rights, safety and well-being and quality of data compliance.
You will:
· Conduct and report all types of onsite monitoring visits
· Be involved in study startup
· Perform CRF review, source document verification and query resolution
· Facilitate site budgets and contract negotiations
· Monitor trial progress on the country level
· Be responsible for site communication and management
· Be a point of contact for in-house support services and vendors
· Communicate with internal project teams regarding study progress
· Participate in feasibility research
· Support regulatory team in preparing documents for study submissions
- College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
- At least 2 years of independent on-site monitoring experience in Australia
- Experience in all types of monitoring visits in Phase II and/or III
- Experience in Inflammatory Bowel Disease, Oncology, Infectious Diseases is a plus
- Full working proficiency in English
- PC skills to be able to work with MS Word, Excel and PowerPoint
- Ability to plan, multitask and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- Ability to travel
What you’ll get:
· Competitive salary
· We offer hybrid work arrangement - 2 days flexi and 3 days in office
· Access to a wide range of employee benefits such as onsite Gym access
· Additional 5 days of wellness leave
· Development and learning opportunities
· Chance to make a real impact in a meaningful industry
About Us
PSI is a passionate, organically grown, and award-winning full-service CRO who dares to be different. As a dynamic and global company, we bring together more than 3000 driven and dedicated experts across 60 countries working collectively to help make a positive impact on patient lives.
How are we different?
PSI is privately owned by the very people who founded the company 30 years ago, and they’re still working here today. As a result, we have grown organically around the globe and have kept our company fully independent, giving us significant advantages and freedoms.
Being a Part of the Team
As a part of the PSI team, you will have a fair degree of ownership and autonomy to make nuanced country-and department-specific adjustments while nurturing the global PSI culture that unites us across six continents.
You will receive continuous support from your global peers and join a fast-paced, innovative, and results-oriented working environment with lean communication lines. We pride ourselves on being approachable, receptive to new ideas, and open to feedback.
Growth Opportunities
PSI is proud to invest in our people, from entry-level team members to senior leaders, helping you identify and hone your unique strengths at every step of your career. From on-the-job learning experiences to formal development programs, our professionals have a variety of opportunities to continue to grow throughout their career.