REMOTE Clinical Trial Associate

Clinical Trial Associate Location: Onsite, Hayward, CA Department: Clinical Development Employment Type: Full Time The Clinical Trial Associate reports to Associate Director, Clinical Development and supports the planning, execution, and operational management of global clinical trials, working closely with internal cross-functional teams, clinical sites, investigators, CROs, sponsors, and external vendors to ensure studies are conducted efficiently, accurately, and in compliance with applicable regulations and company procedures. Study Operations & Site Management- Support planning, coordination, and day-to-day management of global trials from start-up through close-out; track site enrollment, outstanding documents, site questions, and action items; maintain communication with sites, investigators, sponsors, and vendors Documentation & eTMF Management- Maintain communication with sites, investigators, sponsors, vendors, and internal teams; support site management (enrollment tracking, outstanding documents, site questions, action items) Quality, Compliance & Regulatory Support- Ensure GCP/GCLP/ICH compliance; collaborate with QA/Regulatory Affairs; support audits and inspections Data Management Support- Support collection, transfer, reconciliation, and secure storage of study data; track data queries and resolve issues with Data Management maintain trackers, project plans, contact lists, and issue logs Budget, Financial & Risk Management- Support study budgets, POs, invoices, payments, and expense tracking; identify risks/delays and support root-cause analysis Minimum 2 years of experience supporting clinical trials, preferably in the biotechnology, pharmaceutical, medical device, or diagnostic industry

• Meticulous approach to documentation, data, and study records
• Experience supporting global clinical trials
• Experience with eTMF systems and clinical trial terminologies
• Experience supporting clinical study start-up and site activation
• Experience with clinical trial budgets, contracts, invoices, and financial reconciliation
• Experience supporting sponsor audits, regulatory inspections, or internal quality audits
• Understanding of GCP, GCLP, ICH guidelines, FDA regulations, and/or other applicable clinical research regulations and guidelines
• Excellent communication and collaboration skills, with a proactive approach to problem solving, root-cause analysis, quality, and regulatory compliance

Experience with laboratory-related clinical studies or diagnostic product development Bachelor's degree in biology, Life Sciences, or related field required; Associate degree in health science field may be considered with relevant clinical trial experience. At Predicine, you won't just support clinical trials — you'll help ensure the studies driving tomorrow's cancer diagnostics run smoothly, accurately, and on time. If you're organized, detail-oriented, and passionate about making a direct impact on patients through better clinical research, we want to hear from you. Apply today and help us turn breakthrough science into better patient outcomes. We celebrate diversity and are committed to creating an inclusive environment for all employees.