Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate managing oncology and global clinical trials for Precision for Medicine, a life sciences CRO. Conducting site monitoring, regulatory oversight, and clinical data quality activities.
Responsibilities:
- 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
Requirements:
- 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
Benefits:
- 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
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