Precision For Medicine स्वास्थ्य सेवा और जीवन विज्ञान क्षेत्र में सेवाएँ प्रदान करने वाला एक संगठन है, जो दवा और जैव-प्रौद्योगिकी कंपनियों को उपचार विकसित करने और उन्हें व्यावसायिक रूप से उपलब्ध कराने में सहायता करता है। इसके विशेषज्ञता क्षेत्रों में ऑन्कोलॉजी, दुर्लभ रोग और ऑटोइम्यून स्थितियाँ शामिल हैं। इसका कार्य नैदानिक परीक्षण प्रबंधन, प्रयोगशाला सेवाएँ, जैव-नमूना संग्रह, बायोमार्कर संबंधी क्षमताएँ और विनिर्माण सहायता को जोड़कर जटिल विकास कार्यक्रमों का समन्वय करता है। नैदानिक अनुसंधान प्रक्रिया के दौरान इन सेवाओं को एकीकृत करके Precision For Medicine टीमों को परिचालन संबंधी चुनौतियों से निपटने और संभावित उपचारों को रोगियों तक पहुँचाने की दिशा में आगे बढ़ने में सहायता करता है।
Senior Clinical Research Associate – Oncology (Hong Kong, Remote)
Precision For Medicine is seeking a Senior Clinical Research Associate to oversee oncology and global clinical trials in Hong Kong. The role covers site monitoring, regulatory coordination, patient safety, and clinical data quality.
विवरण
- Lead study site management activities that safeguard patients and support reliable clinical data
- Advise teams on audit readiness, preparation, and follow-up actions
- Create, monitor, and maintain trial management systems, tools, and status reporting
- Coordinate site start-up, investigator feasibility and recruitment, EC/IRB submissions, regulatory records, informed consent materials, notifications, translations, and meetings
- Support study budget negotiations and investigator contract execution as needed
- Assess informed consent procedures, patient safety, data integrity, protocol deviations, and pharmacovigilance matters
- Complete pre-study, initiation, routine monitoring, close-out, and oversight visits in line with protocols, local regulations, ICH-GCP, and SOPs
- Produce monitoring reports, confirmation and follow-up letters, trip reports, communication logs, and related project documentation
- Contribute to patient recruitment, retention, and awareness initiatives
- Review, reconcile, and properly archive Investigator Site Files and Trial Master Files
- Escalate study issues and risks to site staff and Precision project and clinical trial management teams
- Oversee investigational product inventory, reconciliation, storage, security, dispensing, administration, labeling, importation, and returns
- Review EDC/CRF records and patient profiles, resolve queries, and address data discrepancies
- Identify and process Serious Adverse Events in accordance with study procedures
- Prepare for and participate in investigator, sponsor, global monitoring, and clinical training meetings
- Contribute to developing protocols, study documents, CRFs, clinical trial reports, presentations, and training materials
- Coach and train new hires and junior monitors
- Support client and proposal work, including client presentations
- Submit investigator payment requests
- Travel as required by project demands
- Complete additional responsibilities assigned by management
आवश्यकताएँ
- Bachelor’s degree or international equivalent, or a comparable combination of education and experience, ideally in business, science, or healthcare
- At least 3.5 years of on-site monitoring experience
- Experience working on oncology studies
- Experience with global clinical trials
- Advanced proficiency with Microsoft Office, including Outlook, Word, Excel, and PowerPoint
- Fluent written and spoken English
- Working knowledge of the drug development process
- Willingness to travel 60–70%
- Sustained attention to detail and a high level of accuracy
- Customer-focused approach with flexibility and a collaborative working style
- Legal authorization to work in the country of employment without employer sponsorship
लाभ
- Regular full-time employment
- Remote work arrangement in Hong Kong
- Equal Opportunity Employer
- Reasonable accommodation available for applicants with disabilities
- Option to opt out of AI use during the application process