Clinical Trial Associate Predicine, Inc

• 2.

8 Hayward, CA Job Details Full-time 18 hours ago Qualifications Research project management Clinical program budget management Financial data reconciliation Project documentation Expense management Data quality management ICH guidelines Financial data management Contracts Clinical research inspection readiness Clinical quality assurance standards Quality audits Root cause analysis Regulatory compliance analysis Cross-functional collaboration Associate's degree Cross-functional communication Operational budget management FDA regulations Audit support Research compliance audit records management Research compliance quality assurance records management

Full Job Description Clinical Trial Associate Location:

Onsite, Hayward, CA Department:

Clinical Development Employment Type:

Full Time Position Overview:

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. The ideal candidate is highly organized, detail-oriented, proactive, and adaptable, with strong communication and collaboration skills and the ability to effectively manage multiple priorities in a fast-paced clinical development environment.

JOB ROLES & RESPONSIBILITIES

JOB

ROLES & RESPONSIBILITIES

% of Time Primary Responsibilities 25% Study Operations & Site Management

• Support planning, coordination, and day-to-day management of global trials from start-up through close-out; manage timelines, milestones, deliverables; track site enrollment, outstanding documents, site questions, and action items; maintain communication with sites, investigators, sponsors, and vendors 20% Documentation & eTMF Management
• Maintain communication with sites, investigators, sponsors, vendors, and internal teams; support site management (enrollment tracking, outstanding documents, site questions, action items) 15% Quality, Compliance & Regulatory Support
• Ensure

GCP/GCLP/ICH

compliance; support protocol deviation and CAPA documentation; collaborate with QA/Regulatory Affairs; support audits and inspections 15% Data Management Support

• Support collection, transfer, reconciliation, and secure storage of study data; track data queries and resolve issues with Data Management 15% Meeting Coordination & Tracking Tools
• Coordinate study meetings, prepare agendas/minutes, track action items; maintain trackers, project plans, contact lists, and issue logs 10% Budget, Financial & Risk Management
• Support study budgets, POs, invoices, payments, and expense tracking; identify risks/delays and support root-cause analysis Required Qualifications 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 Previous experience managing or coordinating CROs and other clinical vendors 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 Attention to detail, organizational skills, and ability to manage multiple priorities and timelines in a fast-paced environment Excellent communication and collaboration skills, with a proactive approach to problem solving, root-cause analysis, quality, and regulatory compliance Preferred / Highly Desirable Qualifications Experience with laboratory-related clinical studies or diagnostic product development Education 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. Advanced degree or relevant certification (e.g., CCRP, CCRA) a plus, but not required. Join Us! 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. Predicine is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.