Clinical Research Associate at KlinEra Global Services Inc

Qualifications 

• Bachelor's degree in life science/related field, advanced degree preferred
• Minimum of 3+ years in clinical research industry 
• Solid understanding of GCP guidelines, regulatory requirements (e.g., FDA, EMA), and clinical trial processes
• Excellent organizational, communication, and interpersonal skills.
• Ability to manage multiple priorities and work effectively in a team environment
• Fluency in Mandarin is preferred. We welcome applicants from diverse linguistic backgrounds

Responsibilities 

• Participate in study protocol review and development
• Assist in site selection and qualification process
• Develop study documents such as informed consent forms (ICFs) and study manuals
• Conduct site initiation visits (SIVs) to train site staff on study protocols and procedures
• Verify site capabilities and ensure availability of necessary study materials
• Assist with regulatory document collection and submission
• Perform routine monitoring visits to clinical sites according to the monitoring plan
• Ensure adherence to the protocol, GCP, and applicable regulatory requirements
• Review and verify data accuracy and completeness in source documents and case report forms (CRFs)
• Track subject recruitment and enrollment status at clinical sites
• Ensure timely resolution of data queries and discrepancies
• Monitor investigational product (IP) accountability and storage conditions
• Review safety data and ensure proper documentation and reporting
• Conduct close-out visits to ensure completeness of study documentation and data
• Assist in the resolution of outstanding issues and data queries
• Ensure proper archiving of study documents and materials
• Maintain regular communication with study sites, investigators, and sponsors
• Provide study progress updates and reports to project teams and stakeholders