Clinical Trial Associate

Predicine, Inc • Hayward, CA

1d • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• Experience with laboratory-related clinical studies or diagnostic product development

Responsibilities

• 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
• Maintain communication with sites, investigators, sponsors, vendors, and internal teams; support site management (enrollment tracking, outstanding documents, site questions, action items)
• Ensure GCP/GCLP/ICH compliance; support protocol deviation and CAPA documentation; collaborate with QA/Regulatory Affairs; support audits and inspections
• Support collection, transfer, reconciliation, and secure storage of study data; track data queries and resolve issues with Data Management
• Coordinate study meetings, prepare agendas/minutes, track action items; maintain trackers, project plans, contact lists, and issue logs
• Support study budgets, POs, invoices, payments, and expense tracking; identify risks/delays and support root-cause analysis

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level