
Sr. Clinical Research Associate
- Shanghai
- Permanent
- Full-time
- Coordinate and support all activities related to clinical trials, assisting managers in their execution.
- Assist in site activation activities, including gathering necessary documentation.
- Review data for quality and completeness, ensuring timely submission to data management and supporting patient safety and eligibility.
- Coordinate with sites to finalize budget worksheets and contractual agreements, maintaining accurate site-level information on the clinical trials registry.
- Support the study team with regulatory submissions, maintain the Electronic Library and Records Archive, and attend investigator meetings as required.
- BA/BS with at least 2 years of experience or MBA/MS with any years of experience
- Demonstrated success in prior roles, including within matrix organizations
- Deep understanding of quality and regulatory requirements across various countries
- Knowledge of International Conference on Harmonization Good Clinical Practices and local regulations
- Proficiency in applications used in clinical trials
- SOP compliance knowledge and expertise on all relevant SOPs
- Effective verbal and written communication skills, and fluency in English
- A Master's degree combined with relevant therapeutic area experience
- High level of project management skills
- Strong analytical and problem-solving skills
- Ability to work independently and as part of a team
- Excellent organizational and time management skills
- Strong attention to detail
- Proficiency in Microsoft SharePoint and SharePoint Designer
- Ability to adapt to changing priorities and work in a fast-paced environment