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.

Learn more about this Employer on their Career Site