Clinical Research Associate II
P
Precision for MedicineClinical Solutions
ChinaFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- Minimum of 2 years of on-site monitoring experience; 1 year oncology experience
- Required Skills
- Excel VBAMicrosoft Office
Requirements
- Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline
- Minimum of 2 years of on-site monitoring experience
- 1 year oncology experience
- Global Clinical Trial experience
- High proficiency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)
- Customer service demeanor; demonstrate flexibility and teamwork
- Ability to focus on detail for extended periods of time, high attention to accuracy
- Fluency in English communication, verbally and in writing
- Working knowledge of the drug development process
- Solid experience in clinical research or related experience (Preferred)
- Excellent organizational skills (Preferred)
- Ability to work efficiently in a remote work environment (Preferred)
Responsibilities
- Oversees all aspects of study site management to ensure patient safety and data quality.
- Provides guidance at the site and project level towards audit readiness standards.
- Updates, tracks and maintains study specific trial management tools/systems, and status reports.
- Manages site start up procedures including feasibility, recruitment, EC/IRB submissions, and regulatory document review.
- Assists the negotiation of study budgets and the execution of investigator contracts.
- Verifies the process of obtaining informed consent has been adequately performed and documented.
- Independently conducts all forms of site visits (pre-study, initiation, routine monitoring, close-out).
- Documents activities via confirmation letters, follow-up letters, trip reports, and communication logs.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
- Communicates effectively and proactively with site personnel and Precision Project and Clinical Trial Management.
- Performs investigational product (IP) inventory, reconciliation and reviews storage and security.
- Performs data review activities, including remote EDC CRF and patient profiles review, and query resolution.
- Identifies and processes Serious Adverse Events according to defined procedures.
- Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies.
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