Senior Clinical Research Associate

This is a fully remote position, open to applicants in Hong Kong.

📋 Description

• Manage all facets of study site operations to ensure patient safety and deliver high-quality clinical data.

• Offer guidance on audit preparedness and assist in the preparation and follow-up of audit activities.

• Develop, monitor, and maintain trial management tools, systems, and status reports.

• Oversee site initiation, investigator feasibility and recruitment, EC/IRB submissions, regulatory documents, informed consents, notifications, translations, and meetings.

• Support study budget negotiations and the execution of investigator contracts as necessary.

• Ensure the verification of informed consent processes, patient safety, clinical data integrity, protocol deviations, and pharmacovigilance issues.

• Conduct pre-study, initiation, routine monitoring, close-out, and oversight visits in compliance with protocols, local regulations, ICH-GCP, and SOPs.

• Compile monitoring reports, confirmation letters, follow-up letters, trip reports, communication logs, and other project documentation.

• Aid in strategies for patient recruitment, retention, and awareness.

• Review and reconcile Investigator Site Files and Trial Master Files, ensuring appropriate archiving.

• Communicate study-related issues and risks to site personnel and Precision project and clinical trial management teams.

• Manage inventory of investigational products, including reconciliation, storage, security, dispensing, administration, labeling, import, and return.

• Conduct reviews of EDC/CRF and patient profiles, resolving queries and data discrepancies.

• Identify and manage Serious Adverse Events in accordance with study protocols.

• Prepare for and participate in investigator, sponsor, global monitoring, and clinical training meetings.

• Assist in the development of protocols, study documents, CRFs, clinical trial reports, presentations, and training materials.

• Mentor and train new hires and junior monitors.

• Engage in client and proposal activities, including client presentations.

• Initiate requests for investigator payments.

• Travel as required based on project needs.

• Execute additional tasks as assigned by management.

⛳️ Requirements

• Bachelor's degree or an international equivalent, or a comparable combination of education and experience, preferably in business, science, or healthcare.

• At least 3.5 years of experience in on-site monitoring.

• Experience in oncology is preferred.

• Familiarity with global clinical trials.

• High proficiency in Microsoft Office Suite, including Outlook, Word, Excel, and PowerPoint.

• Proficient in English communication, both verbally and in writing.

• Working knowledge of the drug development process is essential.

• Willingness to travel (60-70%).

• Strong attention to detail and accuracy over extended periods.

• Customer service orientation with a flexible and collaborative approach.

• Candidates must be legally authorized to work in the country of employment without sponsorship from the employer.

🏝️ Benefits

• Regular full-time employment.

• Remote working option available in Hong Kong.

• Equal Opportunity Employer.

• Reasonable accommodations for applicants with disabilities.

• Option to opt-out of AI during the application process.