精鼎医药
Clinical Research Associate - FSP
Clinical Research Associate - FSP
发布于 大约 15 小时前普通员工/个人贡献者
香港特别行政区
中级经验
全职员工
混合式弹性办公
本科
医疗、制药与临床研究
ICH-GCP
CTMS
EDC
Problem Solving
Clinical Research
Monitoring
AI 估算 · 25k–45k
Based on mid-level CRA role in Hong Kong, with experience requirement and global CRO company, market rate for similar positions
职位详情
关于这个职位
This role involves managing clinical trial sites for a global pharmaceutical company under Parexel's FSP team. You will ensure site compliance, data integrity, and study progress through on-site and remote monitoring. The position requires building relationships with investigators and resolving site issues independently.
最低要求
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
工作职责
Maintenance (from initiation through close out):
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 top global CRO (Parexel) and gain exposure to multiple sponsors.
- Develop deep expertise in clinical trial management and regulatory compliance.
- Mix of on-site and remote work provides flexibility.
- Opportunity to build a strong network in the pharmaceutical industry.
- Significant travel requirements (extensive travel time).
- High responsibility for site performance and data integrity, pressure to meet deadlines.
- Requires strong self-management and ability to work in a virtual team environment.
- This role is ideal for experienced clinical research professionals who enjoy independent work, travel, and have strong organizational and problem-solving skills.
缺点 / 挑战
暂无明显挑战项
角色解读
- Advance to Senior CRA or Lead CRA with more complex studies and mentoring.
- Move into Project Management or Clinical Operations management roles.
- Specialize in therapeutic areas or become a Subject Matter Expert (SME) in monitoring.
- Manage clinical trial sites, ensuring compliance with protocols, GCP, and regulations.
- Conduct on-site and remote monitoring visits, including qualification, initiation, and routine visits.
- Build relationships with investigators and site staff, resolving issues and providing training.
- Oversee data quality, supply management, payment, and documentation in CTMS and TMF.
- Strong knowledge of ICH-GCP, local regulations, and clinical trial methodology.
- Excellent communication, problem-solving, and interpersonal skills.
- Ability to work independently with minimal supervision and prioritize multiple tasks.
- Proficiency in CTMS, EDC, MS Office, and attention to detail.
申请策略
- Research Parexel's FSP model and client focus to tailor your application.
- Highlight your adaptability to different sponsor requirements and flexibility in travel.
- Emphasize site management experience and specific monitoring responsibilities.
- Detail knowledge of ICH-GCP and local regulations with examples of audit readiness.
- Showcase problem-solving instances and ability to manage multiple sites.
- Include proficiency with CTMS, EDC, and other relevant systems.
- Obtain certifications (e.g., ACRP or SOCRA) to enhance credibility.
- Improve knowledge of therapeutic areas relevant to the sponsor's portfolio.
面试指南
- Use STAR method (Situation-Task-Action-Result) for behavioral questions.
- Demonstrate knowledge of ICH-GCP by referencing specific guidelines.
- Show proactive communication and problem-solving mindset.
- Describe a challenging site issue you resolved and how you handled it.
- How do you ensure data integrity during monitoring visits?
- Explain your approach to building relationships with investigators.
- How do you prioritize tasks when managing multiple sites with competing deadlines?
- What is your understanding of risk-based monitoring?
职位点评
72
综合评分
Mid-level CRA role at a top CRO, strong development potential but requires significant travel and flexibility.
更适合这类人
Ideal for motivated clinical research professionals focused on career growth and expertise, who can manage travel demands.
表现最好
成长发展
相对薄弱
工作生活
薪资福利70
成长发展80
工作生活65
使命价值75
薪资福利
70中等
The salary is competitive for mid-level CRA in Hong Kong, with benefits likely offered by Parexel. However, the base salary is not explicitly stated, so uncertainty exists.
薪资信号未披露（AI估算：25K-45K/月）
成长发展
80较高
The role offers significant growth in clinical research expertise, exposure to global sponsors, and potential to become an SME. Mentoring and performance development conversations are mentioned.
技术前沿主流现代技术
技术栈Clinical Trial Management System (CTMS)、EDC、IVRS、ICH-GCP
成长机会Performance Development Conversation(s)、Develop expertise to become a subject matter expert
业务类型ambiguous
工作生活
65中等
The role requires 1-2 days onsite per week and extensive travel, which reduces flexibility. However, remote work is also possible, and no overtime is explicitly mentioned.
工作模式混合式弹性办公
办公地点未明确
加班情况未提及（无法判断）
使命价值
75中等
Clinical research contributes to medical advancement and patient health. The role directly impacts trial quality and compliance, offering a sense of purpose.
行业发展稳定成熟行业
社会影响正向社会影响力较高
创新程度稳健跟随主流
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