Senior Clinical Research Associate

🔥 18 minutes ago

🇭🇰 Hong Kong – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• 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