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Clinical Research Associate I - Senior (Core Team)
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Clinical Research Associate I - Senior (Core Team)

发布于 大约 14 小时前

普通员工/个人贡献者

Kowloon, Kowloon, Hong Kong
高级经验
全职员工
仅现场办公
本科
临床研究
Clinical Research
Communication Skills
Ctms
Edc
Ich-Gcp
Ivrs
On-Site Monitoring

AI 估算 · 25k–55k

Competitive salary for clinical research role in Hong Kong, reflecting high living cost and specialized skills.

职位详情

关于这个职位

This is a clinical research associate role focusing on site management and monitoring for clinical trials. You will act as Parexel's direct contact with study sites, ensure protocol compliance, perform on-site visits, and resolve issues. The role requires strong communication skills, attention to detail, and willingness to travel extensively.

最低要求

Skills:

Sound problem solving skills.
Able to take initiative and work independently, and to proactively seek guidance when necessary.
Advance presentation skills.
Client focused approach to work.
Ability to interact professionally within a client organization.
Flexible attitude with respect to work assignments and new learning.
Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
Willingness to work in a matrix environment and to value the importance of teamwork.
Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
Strong interpersonal, verbal, and written communication skills.
Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.
Effective time management in order to meet study needs, team objectives, and department goals.
Developing ability to work across cultures.
Shows commitment to and performs consistently high-quality work.
Ability to successfully work in a (‘virtual’) team environment.
Consulting Skills
Great attention to detail.
Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.
Holds a driver’s license where required.
Knowledge and Experience:
Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Education:
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Additional Requirements:
Based in Hong Kong.
Fluent in Cantonese and English- (both written and spoken).

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

  • Parexel is a global CRO with a strong reputation, providing exposure to diverse clinical trials and international regulatory standards.
  • The role enhances your skills in site management, regulatory compliance, and data quality, which are highly valued in the pharmaceutical industry.
  • Working in Hong Kong offers a dynamic environment and competitive compensation.
  • You will gain broad experience across different phases of trials and therapies.
  • The role requires extensive travel, which can be physically and mentally demanding.
  • You will manage multiple sites with complex issues, requiring strong problem-solving and autonomy.
  • High attention to detail and strict compliance requirements can be stressful, especially during audits and inspections.
  • This role is ideal for individuals with clinical research experience who enjoy a mix of independent work and client interaction, are comfortable with frequent travel, and want a challenging career in the CRO industry.

缺点 / 挑战

暂无明显挑战项

角色解读

  • You can progress from CRA to Senior CRA, then to Clinical Operations Lead or Clinical Project Manager roles.
  • With experience, you may specialize in therapeutic areas or move into regulatory affairs, medical writing, or clinical quality.
  • Parexel offers opportunities for continuous learning and development, including potential advancement into leadership positions.
  • You will be the main point of contact between Parexel and clinical trial sites, overseeing site performance and protocol compliance from study initiation to close-out.
  • You will conduct on-site and remote visits to monitor data quality, address issues, and ensure regulatory and ICH-GCP adherence.
  • You will collaborate with investigators and site staff, managing study-related documentation, supplies, and payment status.
  • You will contribute to project planning, provide feedback to team members, and support audit/inspection readiness.
  • Strong understanding of clinical research methodology, regulatory requirements (ICH-GCP), and site management practices.
  • Excellent communication and interpersonal skills to build relationships with investigators and cross-functional teams.
  • Proficiency in CTMS, EDMS, and MS-Office
  • ability to analyze data and identify quality issues.
  • High flexibility and willingness to travel extensively, with effective time management and problem-solving abilities.

申请策略

  • Tailor your CV to emphasize relevant clinical trial experience and align your language with the job description.
  • Research Parexel's services, therapeutic areas, and company culture to show genuine interest in the role.
  • Highlight your site management experience and specific clinical research projects you have handled.
  • Emphasize your familiarity with ICH-GCP and local regulations, as well as any experience with CTMS/EDC systems.
  • Showcase problem-solving abilities, attention to detail, and your ability to work independently.
  • Mention your proficiency in Cantonese and English, and your flexibility to travel.
  • If less experienced, consider obtaining certification like ACRP or SOCRA to strengthen your credentials.
  • Familiarize yourself with Parexel's systems and recent developments in clinical trial technology.

面试指南

  • Use the STAR method (Situation, Task, Action, Result) to structure answers that demonstrate your problem-solving and site management skills.
  • For compliance questions, emphasize your knowledge of ICH-GCP and your attention to detail, providing concrete examples of ensuring compliance.
  • Show your client-focused approach by explaining how you balance both Parexel's and the sponsor's expectations while maintaining site relationships.
  • Describe your experience in managing clinical trial sites and ensuring protocol compliance.
  • How do you handle a site that is not meeting enrollment targets?
  • Walk us through how you would resolve a data integrity issue at a site.
  • How do you prioritize multiple tasks when managing several sites with competing deadlines?
  • Explain a time you had to build a positive relationship with a difficult investigator.

职位点评

64
综合评分

Global CRO role with strong development opportunities, decent salary, but demanding travel and no remote work.

从薪资福利、成长空间、工作节奏和岗位方向综合评估，方便横向比较。

更适合这类人
This role is best suited for candidates who prioritize professional growth and career development, are willing to trade work-life balance for global clinical research experience, and find purpose in contributing to clinical trials.
表现最好
成长发展
相对薄弱
工作生活
薪资福利65
成长发展80
工作生活35
使命价值70

薪资福利

65中等

The role offers a competitive salary for Hong Kong, but the extensive travel and high-pressure environment may reduce work-life balance. Overall compensation is above average for clinical research roles.

薪资信号未披露（AI估算：25K-55K/月）

成长发展

80较高

This position provides strong professional development through exposure to international trials, potential to become a subject matter expert, and opportunities for advancement within a global CRO.

技术前沿非技术岗（不适用）
成长机会Develop expertise to become a subject matter expert、Provide input and feedback for Performance Development Conversation(s)、Work in a self-driven capacity
业务类型ambiguous

工作生活

35较低

The role requires extensive travel and is based on-site at clinical sites, which can be demanding. The job description mentions flexibility in attitude but not remote work or work-life balance, so lifestyle satisfaction is low.

工作模式仅现场办公
办公地点未明确
加班情况JD含高强度暗示词

使命价值

70中等

Working in clinical research contributes to advancing medical treatments and patient care, providing a sense of purpose. The role ensures trial integrity and patient safety, which is meaningful, though the direct impact may not be immediately visible.

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preserving patient safety
创新程度稳健跟随主流

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