高级临床研究专员
Senior Clinical Research Associate
PSI 是一家在行业内拥有 30 年经验的领先合同研究组织，为客户提供稳定与创新相结合的完美平衡，同时也为员工提供良好的工作环境。我们专注于在多种治疗领域提供高质量且按时的服务。
作为高级临床监查员（Senior CRA），您将负责与项目相关方进行一线沟通，确保各种治疗领域的临床研究项目的进度、目标和标准。您将建立并维护与临床现场和研究者的联系。您的重点将放在受试者的权利、安全和福祉以及数据合规性的质量上。
这是一个位于斯洛伐克境内的自由职业（承包商）居家办公职位。
您的职责包括：
· 进行并报告所有类型的现场监查访问
· 执行病例报告表（CRF）审查、原始文件验证和问题解决
· 负责现场沟通和管理
· 监督每个现场的研究活动、进度和时间表
· 作为内部支持服务和供应商的联系人
· 支持质量控制，如合规性监查和报告审查
- 生命科学（或类似领域）学士或硕士学位，或同等教育、培训和经验组合
- 在斯洛伐克有独立的现场监查经验
- 具备 II 期和 III 期所有类型监查访问的可证明经验
- 斯洛伐克语和英语流利
- 有支持肿瘤学和胃肠病学研究的经验者优先
- 有效的驾驶执照及出差能力
- 熟练使用 Microsoft Office
- 具备沟通、协作和解决问题的能力是必需的
做出正确的选择，将您的职业生涯提升到全新高度。加入一家重视员工并投资于其职业发展和成功的公司。我们的招聘流程简单直接，我们将全程陪伴您每一步。我们会提供信息指导和支持，使您的体验尽可能顺畅。
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 Senior CRA to manage the clinical aspects of full-service global projects in Australia. As a Senior CRA 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.
· Training, mentoring and supervising study level responsibilities for Jr. CRAs
· Preparation, conduct, and reporting of selection, initiation, routine and closeout monitoring visits
· Delivering training of investigators, site staff and project teams
· Work with complex studies
· Perform CRF review, source document verification and query resolution
· Be responsible for site communication and management
· Be involved in site identification process
· Contact for clinical investigators, vendors and support services in regard to study progress
· Participate in feasibility research
· Preparation and delivering of presentations at Investigator’s Meetings
· Preparation for and attendance at company’s audits; resolution of audit findings
· Support to Regulatory Affairs in procurement of site regulatory documents
· Maintenance of study-specific automated tracking systems
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- At least 4 years of independent on-site monitoring experience in Australia
- Experience in all types of monitoring visits in Phase II and/or III
- Availability to travel
- Experience in Inflammatory Bowel Disease, Oncology, Infectious Diseases is a plus
- Proficiency in MS Office applications
- Ability to plan and work in a dynamic team environment
- Communication, collaboration, and problem-solving skills
- If you like to train and support others on their clinical research steps, and are also looking forward to future Lead Monitor roles, this position may just be the right one for you.
What you’ll get:
· Competitive salary
· We offer hybrid work arrangement - 2 days flexi and 3 days in office (Sydney-based only)
· Access to a wide range of employee benefits such as onsite Gym access (Sydney-based only)
· Additional 5 days of wellness leave
· Development and learning opportunities
· Chance to make a real impact in a meaningful industry
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.