Precision For Medicine farmatsevtika va biotexnologiya kompaniyalariga davolash usullarini ishlab chiqish va tijoratlashtirishda yordam beradigan sog‘liqni saqlash hamda hayotiy fanlar xizmatlari tashkilotidir. Uning tajribasi onkologiya, kam uchraydigan kasalliklar va autoimmun holatlarni qamrab oladi. Tashkilot klinik tadqiqotlarni boshqarish, laboratoriya xizmatlari, biologik namunalarni yig‘ish, biomarker imkoniyatlari va ishlab chiqarishni qo‘llab-quvvatlash xizmatlarini birlashtirib, murakkab ishlab chiqish dasturlarini muvofiqlashtiradi. Ushbu xizmatlarni klinik tadqiqot jarayonining turli bosqichlari bilan bog‘lash orqali Precision For Medicine jamoalarga operatsion muammolarni hal qilish va istiqbolli davolash usullarini bemorlarga yetkazish yo‘lida ilgarilashga yordam beradi.
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.
Tavsif
- 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
Talablar
- 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
Imtiyozlar
- 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