Clinical Research Associate II (CRA II)
职位描述你对临床研究充满热情，并渴望在医疗保健行业产生重大影响？我们正在寻找专门的临床研究副会员 II 加入我们的团队。在这个角色中，你将成为临床研究的所有阶段的主要网站联系人，确保遵守规则，并为我们的临床试验取得成功做出贡献。如果你喜欢与数据和技术信息合作，这是你的完美机会！作为临床研究副会员 II,你将在与研究地点建立和维持密切关系方面发挥关键作用，促进沟通并确保我们的研究协议得到有效执行。你将有机会为我们临床研究流程的持续改善做出贡献.####重点责任 - 自主管理从开始到接近的临床试验场所。- 进行现场监测访问，包括 SQV,SIV,例行监测和离近访问。- 确保遵守协议，ICH-GCP,赞助商要求以及当地法规。- 审查源文件和研究数据以确保质量和患者安全。- 确定，升级和解决与现场相关的问题和风险。- 准备监测访问报告并保持精确的研究文档。- 在 CTMS,eTMF 和其他临床系统中维护检查准备记录。- 与调查人员和现场人员建立有效关系。- 与跨职能团队合作支持研究提供和现场性能。#####资格 - 本科学位 - 自主地进行在医院和研究中心的现场监测访问经验。- 经历整个临床试验生命周期内的网站管理经验。- 经验编制监测访问报告和维持临床试验文件。- 对 ICH-GCP,临床试题流程以及法规要求的强有力的知识。- 高水平的英语能力 （书面和口头）. - 强大的沟通，组织和利益相关者管理技能。#####优先 - 在 CRO 或药品公司的经验。- 支持审计和检查的经验；- 多个治疗领域和临床试卷阶段的经验".#ClinicalTrialsBR"我们是一个认证不值的人物不同特征，才华和承诺的企业机构。
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Job Description
Are you passionate about clinical research and eager to make a significant impact in the healthcare industry? We are looking for a dedicated Clinical Research Associate II to join our team. In this role, you will be the primary site contact throughout all phases of clinical research studies, ensuring compliance with regulations and contributing to the success of our clinical trials. If you enjoy working with data and technical information, this is the perfect opportunity for you!
As a Clinical Research Associate II, you will play a crucial role in developing and maintaining strong relationships with study sites, facilitating communication, and ensuring that our research protocols are executed effectively. You will have the chance to contribute to the continuous improvement of our clinical research processes.
#### Key Responsibilities
- Independently manage clinical trial sites from initiation through close-out.
- Conduct on-site monitoring visits, including SQV, SIV, Routine Monitoring, and Close-Out Visits.
- Ensure compliance with protocols, ICH-GCP, sponsor requirements, and local regulations.
- Review source documents and study data to ensure quality and patient safety.
- Identify, escalate, and resolve site-related issues and risks.
- Prepare monitoring visit reports and maintain accurate study documentation.
- Maintain inspection-ready records in CTMS, eTMF, and other clinical systems.
- Build effective relationships with investigators and site personnel.
- Partner with cross-functional teams to support study delivery and site performance.
#### Qualifications
- Bachelor's degree
- Experience independently conducting on-site monitoring visits at hospitals and research centers.
- Experience managing sites throughout the clinical trial lifecycle.
- Experience preparing monitoring visit reports and maintaining clinical trial documentation.
- Strong knowledge of ICH-GCP, clinical trial processes, and regulatory requirements.
- Advanced English proficiency (written and spoken).
- Strong communication, organization, and stakeholder management skills.
#### Preferred
- Experience in CROs and/or pharmaceutical companies.
- Experience supporting audits and inspections.
- Experience across multiple therapeutic areas and clinical trial phases.
#ClinicalTrialsBR
"Temos orgulho de ser uma empresa que acredita no valor de trazer pessoas de diferentes perfis, talentosas e comprometidas. A maneira mais rápida de revolucionar a inovação é quando ideias diversas se reúnem em um ambiente inclusivo. Incentivamos nossos colaboradores a abordar os problemas coletivamente e desafiar de forma respeitosa o raciocínio uns dos outros. Somos um empregador focado em promover iguais oportunidades aos nossos colaboradores, comprometido a incentivar um local de trabalho inclusivo e diversificado."
**Additional location(s) Compensation Information:**
**Required Skills:**
Accountability, Accountability, Adaptability, Adverse Event Reporting System, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Conflict Management, Cultural Awareness, Customer Centricity, Customer-Focused, Data Analysis, Data Reporting, Document Management, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Growth Mindset, Multitasking, Protocol Adherence, Regulatory Affairs Management, Regulatory Compliance, Regulatory Inspections {+ 5 more}
**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:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
No Travel Required
**Flexible Work Arrangements:**
Not Applicable
**Shift:**
Not Indicated
**Valid Driving License:**
No
**Hazardous Material(s):**
N/A
**Job Posting End Date:**
10/29/2026
***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.**