精鼎医药
Clinical Research Associate I/II/Senior
Clinical Research Associate I/II/Senior
发布于 大约 15 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
Clinical Research
Cra
Ctms
Edc
Ich-Gcp
Ms Office
Problem Solving
Teamwork
AI 估算 · 10k–25k
薪资基于台湾CRA市场水平，初级至高级范围较宽，考虑国际CRO公司标准，月薪折合人民币约10k-25k，年终通常1个月以上。
职位详情
关于这个职位
作为精鼎医药的临床研究助理，您将直接负责临床试验中心的全面管理，包括中心筛选、启动、日常监督和关闭
您需要与研究者建立良好关系，确保试验符合GCP和法规要求，独立解决现场问题，并保证数据质量
该职位适合有临床研究或中心管理经验的专业人士，需要频繁出差
最低要求
Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
工作职责
Maintenance (from initiation through close out):
Act as Parexel’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
Build relationships with investigators and site staff.
Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
Address/evaluate/resolve issues pending from the previous visit, if any.
Follow-up on and respond to appropriate site related questions.
Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
Conduct remote visits/contacts as requested/needed.
Generate visit/contact report.
Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
Assess & manage test article/study supply including supply, accountability and destruction/return status.
Review & follow-up site payment status.
Follow-up on CRF data entry, query status, and SAEs.
Conduct on-site study-specific training (if applicable).
Perform site facilities assessments.
Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution.
Overall Accountabilities from Site Identification to Close out:
Ensure timely and accurate completion of project goals and update of applicable trial management systems.
Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
Ensure that assigned sites are audit and inspection ready.
Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
Show commitment and perform consistent high-quality work.
Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
Provide input and feedback for Performance Development Conversation(s).
Proactively keep manager informed about work progress and any issues.
Develop expertise to become a subject matter expert.
Work in a self-driven capacity, with limited need for oversight.
Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)
AI 洞察
优缺点分析
优点
- Work with a global leading CRO, gaining exposure to diverse clinical trials and international standards.
- High demand for experienced CRAs, offering strong career stability and growth opportunities.
- Develop expertise in clinical research and regulatory compliance, valued in the pharmaceutical industry.
- Extensive travel required, which can be physically and mentally demanding.
- High responsibility for data integrity and patient safety, requiring meticulous attention to detail.
- Managing multiple sites and tight timelines can lead to high pressure and work intensity.
- This role is ideal for individuals with strong organizational and problem-solving skills, who are comfortable with frequent travel and enjoy working independently in a regulated environment.
缺点 / 挑战
暂无明显挑战项
角色解读
- Progress from CRA I to Senior CRA, then to Lead CRA or Clinical Operations Manager.
- Opportunity to specialize in therapeutic areas or become a subject matter expert (SME) in monitoring or regulatory affairs.
- Move into roles such as Clinical Trial Manager, Project Manager, or Quality Assurance.
- Manage clinical trial sites from initiation to close-out, ensuring protocol compliance and data integrity.
- Build and maintain relationships with investigators and site staff, providing support and training.
- Perform on-site and remote monitoring visits, resolve issues, and generate visit reports.
- Collaborate with internal teams to meet project milestones and ensure audit readiness.
- Strong knowledge of ICH-GCP guidelines and local regulatory requirements.
- Excellent problem-solving and analytical skills to identify and resolve site issues.
- Effective communication and interpersonal skills to interact with clinical investigators and team members.
- Proficiency in Clinical Trial Management Systems (CTMS), EDC, and MS Office.
申请策略
- Tailor your CV to align with the specific therapeutic areas mentioned in the job description.
- Be prepared to discuss how you handle challenging site situations and maintain compliance under pressure.
- Highlight site management experience, including specific trials managed and outcomes achieved.
- Emphasize knowledge of ICH-GCP and local regulations, with any relevant certifications.
- Showcase analytical and problem-solving skills with examples of resolving complex site issues.
- Include proficiency in CTMS, EDC, and MS Office, and any experience with electronic trial master files.
- Consider obtaining certification like ACRP or SOCRA to demonstrate commitment to the field.
- Strengthen project management and communication skills through courses or on-the-job practice.
面试指南
- Use the STAR method (Situation, Task, Action, Result) to structure your answers, focusing on your role and outcomes.
- Demonstrate knowledge of regulations by referencing specific ICH-GCP guidelines or local requirements.
- Show proactive communication and teamwork by highlighting how you collaborated with site staff and internal teams.
- Describe your experience with site initiation and close-out processes.
- How do you handle non-compliance issues at a clinical site?
- Can you provide an example of a time you resolved a complex problem during a monitoring visit?
- How do you prioritize tasks when managing multiple sites with competing deadlines?
- What steps do you take to ensure data integrity and quality in clinical trials?
职位点评
66
综合评分
Global CRO CRA role with strong career development, competitive pay, but heavy travel and limited flexibility.
更适合这类人
This position is best suited for career-driven individuals who prioritize professional growth and skill development over work-life balance.
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80
工作生活40
使命价值70
薪资福利
75中等
The salary is competitive for the CRO industry in Taiwan, with typical benefits like health insurance and bonus. However, the specific benefits are not detailed in the JD.
薪资信号未披露（AI估算：10K-25K/月）
成长发展
80较高
The role offers strong career growth in clinical research, with opportunities to become a subject matter expert and progress to senior positions. The JD emphasizes training and development.
技术前沿主流现代技术
技术栈CTMS、EDC、IVRS、SIS、ICH-GCP、MS Office
成长机会Develop expertise to become a subject matter expert、Performance Development Conversation
业务类型ambiguous
工作生活
40较低
The role requires extensive travel and on-site visits, with no mention of remote work flexibility. Work-life balance may be challenging due to travel demands.
工作模式仅现场办公
办公地点未明确
加班情况未提及（无法判断）
使命价值
70中等
Working in clinical research contributes to advancing medical treatments, which has positive social impact. The industry is stable and growing.
行业发展稳定成熟行业
社会影响中性/一般
创新程度稳健跟随主流
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