Clinical Research Coordinator
1 month ago
Costello Medical is seeking a highly skilled Clinical Research Coordinator to join our team in Shanghai. The successful candidate will be responsible for coordinating and managing real-world evidence (RWE) studies, from set-up through to reporting, ensuring compliance with regulatory standards and delivery of high-quality results.
Key Responsibilities
- Ethics and Regulatory Compliance:
- Prepare and submit ethics applications and other regulatory documents to ensure compliance with local and international regulations
- Maintain up-to-date knowledge of regulatory requirements and ensure all studies adhere to these standards
- Data Management and Analysis:
- Oversee data collection, entry, and management for studies conducted in China, ensuring accuracy and completeness
- Collaborate with statisticians and analysts to perform data analysis and prepare comprehensive reports of study findings
- Study Coordination and Management:
- Coordinate the design, execution, and reporting of RWE studies specific to the China market
- Manage project timelines, resources, and deliverables to ensure high-quality and timely completion of projects
- Site Setup and Support:
- Identify and coordinate with clinical research sites in China, ensuring all necessary infrastructure and protocols are in place
- Facilitate smooth setup and ongoing support for the duration of the study
Requirements
- A minimum of 1-3 years of experience in clinical research or a related field, with a focus on study set-up, ethical approval, and project management
- Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment
- Familiarity with the China market is desirable. Experience in additional markets would be beneficial
- A degree level qualification in a scientific discipline (minimum second upper honours, GPA 4/5, CAP 4/5 or equivalent)
- A comprehensive understanding of RWE or clinical research methods and study designs, with a willingness to further develop this knowledge
- Experience in working collaboratively within a team and supporting the development of junior colleagues or team members
- Strong organisational skills with the ability to manage multiple tasks and ensure timely delivery of projects
- The capacity to maintain exceptional customer service and quality of deliverables under multiple competing demands
- An exceptional written and spoken fluency in Mandarin (equivalent to native Mandarin language skills) and excellent written and spoken fluency in English
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