艾昆纬
(Senior) Clinical Research Associate (CRA)
(Senior) Clinical Research Associate (CRA)
发布于 大约 4 小时前普通员工/个人贡献者
Taipei , Taipei City, Taiwan
中级经验
全职员工
仅现场办公
本科
医疗、制药与临床研究
Microsoft Office
TMF
ICH
Clinical Research
AI 估算 · 15k–25k
Senior CRA role at top CRO in Taiwan; requires 1+ year experience and specialized regulatory knowledge; market average monthly s
职位详情
关于这个职位
As a Senior Clinical Research Associate at IQVIA, you will be responsible for monitoring clinical trial sites in Taiwan, ensuring compliance with GCP and ICH guidelines. You will manage site selection, initiation, routine monitoring, and close-out visits, while collaborating with study teams to drive patient recruitment and data quality. This role requires strong organizational skills, attention to regulatory details, and effective communication with investigators and sponsors.
最低要求
Bachelor's Degree in scientific discipline or health care preferred. Req
Requires at least 1 year of on-site monitoring experience. Req
Equivalent combination of education, training and experience may be accepted in lieu of degree. Req
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
Good therapeutic and protocol knowledge as provided in company training.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
Written and verbal communication skills including good command of English language.
Organizational and problem-solving skills.
Effective time and financial management skills.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
工作职责
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Collaborate and liaise with study team members for project execution support as appropriate.
If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
AI 洞察
优缺点分析
优点
- Work with a global leader in clinical research, gaining exposure to cutting-edge therapies and international standards.
- High demand for experienced CRAs in Taiwan, offering strong job security and competitive compensation.
- Opportunities to travel within Taiwan and potentially abroad, building a broad network in the life sciences industry.
- Clear career ladder with formal training and mentorship programs to enhance clinical monitoring skills.
- Frequent travel to diverse clinical sites (hospitals, clinics) can lead to irregular hours and work-life balance challenges.
- High responsibility for data integrity and regulatory compliance
- errors can have serious consequences.
- Need to manage multiple sites simultaneously, requiring excellent prioritization and resilience under tight deadlines.
- This role is ideal for detail-oriented professionals with a background in life sciences who enjoy a mix of independent field work and collaborative team interaction, and who are committed to advancing medical research.
缺点 / 挑战
暂无明显挑战项
角色解读
- Progress to Senior CRA II, then to Lead CRA or Clinical Project Manager roles overseeing entire studies.
- Develop expertise in specific therapeutic areas (e.g., oncology, CNS) to become a subject matter expert.
- Transition into clinical operations management, site management, or regulatory affairs within the CRO or sponsor side.
- Conduct on-site monitoring visits at clinical trial sites to ensure compliance with protocol, GCP, and regulatory requirements.
- Manage site relationships, train site staff on protocol, and track patient recruitment to meet project timelines.
- Oversee data quality by reviewing case report forms, resolving queries, and ensuring proper documentation in Trial Master File.
- Collaborate with project teams and escalate quality issues to maintain study integrity.
- Solid understanding of ICH-GCP guidelines and local regulatory requirements for clinical trials.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint) and ability to use laptops and mobile devices for site work.
- Excellent English communication (written and verbal) for interacting with global sponsors and study teams.
- Strong organizational, problem-solving, and time management skills to handle multiple sites and deadlines.
申请策略
- Tailor your resume to mirror the language of the job description, using keywords like 'site monitoring', 'ICH-GCP', and 'subject recruitment'.
- Research IQVIA's recent clinical trials in Taiwan and mention relevant therapeutic areas in your cover letter to show genuine interest.
- Emphasize your on-site monitoring experience, specifying the number of sites managed and any therapeutic areas covered.
- Highlight your knowledge of ICH-GCP and local regulations, and any experience with regulatory submissions or audits.
- Showcase English proficiency through certifications (e.g., TOEIC) or examples of work with international teams.
- Include metrics such as patient recruitment achievements, data query resolution rates, or successful site initiations.
- If lacking direct site monitoring experience, consider a CRA training program or internship at a CRO to gain hands-on skills.
- Deepen understanding of ICH-GCP guidelines by reviewing official training modules and case studies.
面试指南
- For compliance questions, use the STAR method: describe the Situation, Task, Action, and Result, emphasizing your knowledge of regulations.
- For problem-solving scenarios, outline your step-by-step approach: identify the issue, consult guidelines, escalate if needed, and implement corrective actions.
- For prioritization, demonstrate use of tools (e.g., tracking spreadsheets) and mention how you balance urgent regulatory deadlines with routine monitoring.
- Describe your experience with site monitoring visits. How do you ensure compliance with GCP?
- How do you handle a situation where an investigator is not following the protocol?
- Explain how you prioritize tasks when managing multiple sites with competing deadlines.
- What steps do you take to verify the accuracy of data in case report forms?
- How do you communicate with sites to improve patient recruitment?
职位点评
75
综合评分
Global CRO Senior CRA role in Taiwan: strong developmental opportunities and purposeful work, but requires frequent travel and on-site presence.
更适合这类人
This position best suits candidates who prioritize career growth and skill development over work-life balance, and who find meaning in contributing to clinical research that impacts global health.
表现最好
成长发展
相对薄弱
工作生活
薪资福利75
成长发展85
工作生活60
使命价值80
薪资福利
75中等
Senior CRA positions at global CROs like IQVIA typically offer competitive salaries and benefits (e.g., health insurance, annual bonus). However, the exact package is not disclosed, so compensation is above average but not guaranteed top tier.
薪资信号未披露（AI估算：15K-25K/月）
成长发展
85较高
This role provides substantial growth through hands-on experience with global clinical trials, regulatory expertise, and clear promotion paths. IQVIA is known for strong training programs and career development.
技术前沿主流现代技术
技术栈ICH-GCP、EHR、CTMS
业务类型ambiguous
工作生活
60中等
The role requires heavy travel to clinical sites, which can impact work-life balance. While the JD does not mention remote work or flexible hours, CROs often offer some flexibility between visits. However, frequent onsite presence is mandatory.
工作模式未明确
办公地点市区核心地段
加班情况未提及（无法判断）
使命价值
80较高
Direct contribution to advancing medical treatments and improving patient health outcomes provides strong sense of purpose. IQVIA's mission is patient-centric, and the role ensures ethical and quality clinical research.
行业发展稳定成熟行业
社会影响正向社会影响力较高
使命信号help improve patient outcomes、accelerate development of innovative medical treatments
创新程度积极采用新技术
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