Senior Clinical Research Associate
职位描述 如果你想：- 加入多项奖励的领先生物制药公司 - 成为临床研究合作伙伴日益增长的团队的一部分 - 使用新技术和智能监测工具 - 有工作灵活性和良好的工作与生活平衡申请！在这个职位上，你将负责在一个国家分配协议和地点的性能和合规。你将作为主要网站联系人和网站经理整个临床研究阶段，承担所有分配站点的总体责任并积极发展和扩大临床研究，寻找和开发新的站点的领土。你的关键责任是：- 进行现场访问 （验证访问，启动访问，监测访问，接近访问）并记录清晰，全面和准确的访问与非访问联系报告。-通过监测活动确保：- 在现场生成的数据是完整的，准确的和公正的。- 对象的权利，安全和福祉受到保护。- 按照当地法规，ICH-GCP,赞助商 SOP,协议，网站监控计划和相关文件开展临床研究地点管理/监测活动。- 与其他赞助者的角色合作协调并管理各种任务。- 与调查人员和现场工作人员沟通有关协议行为，招聘，保留，协议偏差，监管文件，网站审计/检查以及总体站点性能的问题。- 根据需要与 CRA 经理，项目经理，治疗区负责人和国家主任合作确定并评估现场绩效，质量或合规问题。- 管理和维护 CTMS,eTMF 等临床试验系统。- 分享知识和最佳实践，培养学习文化以提高团队的效率和能力。- 遵循国家主任所定义的国家战略。如果你有：- 分钟。经验3年，在生物/药物/CRO 领域进行直接站点管理 （监测）- 在现场管理方面具有证明的技能，包括对现场性能和患者招聘的管理。- 良好的 IT 技能，学习和运行新的 IT 应用的能力。- 了解和分析数据/指标能力。- 能够处理复杂的问题，以解决方案为导向的方式工作。- 流利地使用英语 （口头和书面）,以及当地语言，优秀沟通和演示技巧。- 良好理解和实践知识临床研究。
查看英文原文
Job Description
If you want to:
- Join a multi-award-winning leading biopharmaceutical company
- Be part of growing team of Clinical Research Associates
- Use new technology and smart monitoring tools
- Have flexibility of work and good work-life balance
Apply today!
On this position you will be accountable for performance and compliance for assigned protocols and sites in a country. You will act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites and actively develop and expand the territory for clinical research, finding and developing new sites.
Your key responsibilities:
- Conduct site visits (validation visits, initiation visits, monitoring visits, close-out visits) and record clear, comprehensive and accurate visit & non-visit contact reports.
- Ensure by monitoring activities that:
- Data generated at site are complete, accurate and unbiased.
- Subjects' right, safety and well-being are protected.
- Perform clinical study site management/monitoring activities in compliance with local regulations, ICH-GCP, Sponsor SOPs, protocol, Site Monitoring Plan and associated documents.
- Coordinate and manage various tasks in collaboration with other sponsor roles.
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identify and assess site performance, quality or compliance problems in collaboration with CRA Manager, Project Manager, Therapeutical Area Head and Country Director as needed.
- Manage and maintain clinical trial systems such as CTMS, eTMF, etc.
- Share the knowledge and best practices, nurture a learning culture to boost efficiency and competence of our team.
- Follow the country strategy defined by Country Director.
You should apply if you have:
- Min. 3 years of direct site management (monitoring) experience in a bio/pharma/CRO.
- Proven skills in site management, including management of site performance and patient recruitment.
- Good IT skills, ability to learn and operate new IT applications.
- Ability to understand and analyse data/metrics.
- Capable of managing complex issues, works in a solution-oriented manner.
- Fluent in English (verbal and written) and local language, excellent communication and presentation skills.
- Good understanding and working knowledge of clinical research, local regulations, ICH-GCP.
- M.A/ M.Sc degree with strong emphasis in medical/bioscience background.
- Ability to travel domestically and internationally approximately 50% of working time. Expected travelling ~2-3 days/week.
- Valid driving license.
**Additional location(s) Compensation Information:**
**Required Skills:**
Clinical Data Management, Clinical Development, Clinical Reporting, Clinical Research Operations, Clinical Research Organizations (CRO) Management, Clinical Study Management, Clinical Trial Management, Clinical Trials Monitoring, Drug Development, Good Clinical Data Management Practice (GCDMP), On Site Management, Patient Recruitment, Protocol Compliance, Site Management
**Preferred Skills:**
Current Employees apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
**VISA Sponsorship:**
**Travel Requirements:**
**Flexible Work Arrangements:**
Remote
**Shift:**
**Valid Driving License:**
**Hazardous Material(s):**
**Job Posting End Date:**
10/22/2026
***A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.**