Clinical Trial Associate

Clinical Trial Associate

Location: Onsite, Hayward, CA

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:

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.