高级临床研究助理（CRA）
Sr. CRA - Clinical Research Associate
**职位描述**
**高级临床研究助理（CRA）- 职责**
• 建立并维护与研究中心的良好关系，确保试验各阶段关系的连续性。
• 按照ICH-GCP、申办方SOP、当地法律法规、方案、研究中心监查计划及相关文件的要求，执行临床试验研究中心管理/监查活动。
• 深入理解研究方案及相关流程。
• 与其他申办方角色协作，协调并管理各项任务以实现研究中心准备就绪。
• 参与研究中心选择和验证活动，并提供相关意见。
• 使用各种工具进行远程和现场监查与监督，确保：
o 研究中心生成的数据完整、准确且无偏。
o 受试者的权利、安全和福祉得到保护。
• 进行研究中心访问，包括但不限于验证访问、启动访问、监查访问、结题访问，并及时、清晰、全面、准确地记录访问及非访问接触报告。
• 收集、审查并监控研究启动、研究维护和研究结题所需的监管文件。
• 与研究者和研究中心人员沟通与方案实施、招募、保留、方案偏离、监管文件、研究中心审计/检查及整体研究中心表现相关的问题。
• 识别、评估并解决研究中心表现、质量或合规问题，并根据定义的CRA升级路径，在与CRA经理、CRM、TA负责人和CRD合作的情况下，适时进行升级。
• 内部与GCTO国家运营、财务、法规事务、药物警戒、法律和区域运营、总部职能领域合作，外部与供应商、IRB/IEC和监管机构合作，以支持指定的研究中心。
• 在CTMS、eTMF和其他适当系统中管理并维护信息和文档，并按照时间表进行。
• 通过担任流程专家（SME），分享最佳实践，提出持续改进的建议，并根据需要提供培训，为CRA团队知识做出重要贡献。
• 根据需要支持和/或领导审计/检查活动。
• 根据CRD和CRA经理定义的国家策略，参与新潜在研究中心的识别，并与其紧密合作以建立强大的临床研究能力。
查看英文原文
**Job Description**
**Sr CRA- Responsibilities**
• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure: o Data generated at site are complete, accurate and unbiased. o Subjects’ right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed.
• Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
• Contributes strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Following the country strategy defined by CRD and CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
• Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
• Could perform Quality control visits if delegated by other roles and trained appropriately.
**CORE Competency Expectations:**
• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
• Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
• Demonstrated ability to mentor/lead.
• Hands on knowledge of Good Documentation Practices.
• Proven Skills in Site Management including independent management of site performance and patient recruitment.
• Demonstrated high level of monitoring skill with independent professional judgment.
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
• Ability to understand and analyze data/metrics and act appropriately, also in a virtual environment.
• Experience with conducting site motivational visit designed to boost site enrollment.
• Capable of managing complex issues, works in a solution-oriented manner.
• Performs root cause analysis and implements preventative and corrective action.
• Capable of mentoring junior CRAs on process/study requirements and is able to perform co- monitoring visits where appropriate.
**Behavioral Competency Expectations:**
• Demonstrates commitment to Customer focus.
• Works with high quality and compliance mind-set.
• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
• Able to work highly independently across multiple protocols, sites and therapy areas.
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
• Positive mindset, growth mindset, capable of working independently and being self-driven.
• Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.
**Experience and Educational Requirements:**
•Bachelor’s degree (or above) with at least 4 years of direct site management (monitoring) experience in a bio / pharma / CRO.
• 7 years of relevant experience in the healthcare field, including at least 4 years of direct site management (monitoring) experience in bio / pharma / CRO.
**Required Skills:**
Adaptability, Adaptability, Clinical Site Management, Clinical Trial Agreements (CTA), Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Clinical Trials Operations, Competency Management, Conflict Management, Cross-Cultural Awareness, Cultural Awareness, Customer Centricity, Decision Making, Document Management, Growth Mindset, ICH GCP Guidelines, Matrix Management, Multitasking, Patient Recruitment, Product Information, Regulatory Compliance, Relationship Building {+ 6 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)
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**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
75%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
No
**Hazardous Material(s):**
na
**Job Posting End Date:**
09/25/2026
***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.**