Precision For Medicine este o organizație de servicii din domeniul sănătății și științelor vieții, care ajută companiile farmaceutice și de biotehnologie să dezvolte și să comercializeze terapii, având expertiză în oncologie, boli rare și afecțiuni autoimune. Activitatea sa combină gestionarea studiilor clinice, serviciile de laborator, colectarea de probe biologice, capacitățile de analiză a biomarkerilor și sprijinul pentru producție, pentru coordonarea unor programe complexe de dezvoltare. Prin conectarea acestor servicii de-a lungul procesului de cercetare clinică, Precision For Medicine ajută echipele să abordeze provocările operaționale și să ducă potențialele tratamente mai aproape de pacienți.
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.
Descriere
- 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
Cerințe
- 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
Beneficii
- 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