Senior Clinical Research Associate

🔥 0 minutes ago

🌐 China, Singapore – Remote

🇨🇳 China – Remote 🇸🇬 Singapore – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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

• Provide overall support to study sites and clinical project teams engaged in clinical research studies. • Adhere to protocols, SOPs, ICH-GCP, GPP, and country/region-specific regulations. • Act as point of contact for study sites and execute core responsibilities independently across several studies. • Oversee study site management to protect patient safety and ensure data quality. • Guide sites and projects toward audit readiness and support audit preparation and follow-up. • Maintain study-specific trial management tools, systems, and status reports. • Manage site start-up activities when required, including feasibility, investigator recruitment, EC/IRB submissions, regulatory documents, informed consents, notifications, translations, and meetings. • Assist with study budget negotiations and investigator contracts when required. • Verify informed-consent processes and documentation; assess safety, protocol deviations, violations, and pharmacovigilance issues. • Independently conduct pre-study/qualification, initiation, routine monitoring, and close-out visits, both on-site and remotely. • Prepare timely monitoring reports and document activities through required project documents and tracking systems. • Support subject/patient recruitment, retention, and awareness strategies. • Review and reconcile Investigator Site Files with Trial Master Files and ensure essential-document archiving. • Communicate study issues proactively with site personnel and Precision project and clinical trial management teams. • Maintain relationships with investigators and study staff and represent Precision’s quality and professional image. • Manage investigational product inventory, reconciliation, storage, security, dispensing, administration, labeling, import, and return/release. • Perform remote EDC CRF and patient-profile reviews, resolve queries, and assist with data discrepancies. • Identify and process Serious Adverse Events according to study procedures. • Identify site risks, escalate them with proposed contingencies, and own timely resolution. • Attend Investigator Meetings, sponsor meetings, global monitoring/project meetings, and required clinical training. • 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 business, scientific, or healthcare discipline. • Minimum 2 years of on-site monitoring experience. • Minimum 1 year of oncology experience. • Global clinical trial experience. • High proficiency in Microsoft Office, including Outlook, Word, Excel, and PowerPoint. • Customer service demeanour; flexibility and teamwork. • Ability to focus on detail for extended periods and maintain high accuracy. • Fluency in English communication, verbal and written. • Working knowledge of the drug development process. • Travel required (60–70%).

🏖️ Benefits

• Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities • Application data stored in accordance with the Privacy Policy