Senior Clinical Research Associate

• Oversee all aspects of study site management to protect patient safety and ensure high-quality clinical data
• Provide guidance on audit readiness and support audit preparation and follow-up actions
• Establish, track, and maintain trial management tools, systems, and status reports
• Manage site start-up, investigator feasibility and recruitment, EC/IRB submissions, regulatory documents, informed consents, notifications, translations, and meetings
• Assist with study budget negotiation and investigator contract execution when required
• Verify informed consent processes, patient safety, clinical data integrity, protocol deviations, and pharmacovigilance issues
• Conduct pre-study, initiation, routine monitoring, close-out, and monitoring oversight visits in accordance with protocols, local laws, ICH-GCP, and SOPs
• Prepare monitoring reports, confirmation letters, follow-up letters, trip reports, communication logs, and other project documents
• Support patient recruitment, retention, and awareness strategies
• Review and reconcile Investigator Site Files and Trial Master Files and ensure proper archiving
• Communicate study issues and risks to site personnel and Precision project and clinical trial management teams
• Manage investigational product inventory, reconciliation, storage, security, dispensing, administration, labeling, import, and return
• Perform EDC/CRF and patient profile reviews, query resolution, and data discrepancy resolution
• Identify and process Serious Adverse Events according to study procedures
• Prepare for and attend investigator, sponsor, global monitoring, and clinical training meetings
• Assist with protocol, study document, CRF, clinical trial report, presentation, and training material development
• Mentor and train new employees and junior monitors
• Participate in client and proposal activities, including client presentations
• Initiate investigator payment requests
• Travel as necessary according to project needs
• Perform other duties assigned by management

• Bachelor's degree / international equivalent or equivalent combination of education and experience ideally in a business, scientific or healthcare discipline
• Minimum of 3.5 years of on-site monitoring experience
• Oncology experience
• Global Clinical Trial experience
• High proficiency in Microsoft Office, including Outlook, Word, Excel, and PowerPoint
• Fluency in English communication, verbally and in writing
• Working knowledge of the drug development process
• Travel required (60-70%)
• Ability to focus on detail for extended periods and high attention to accuracy
• Customer service demeanour; flexibility and teamwork
• Candidates must be legally authorized to work in the country of employment without employer sponsorship

• Regular full-time employment
• Remote work arrangement in Hong Kong
• Equal Opportunity Employer
• Reasonable accommodation for applicants with disabilities
• AI opt-out option during the application process