Clinical Trial Associate

Predicine, Inc; Hayward (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Predicine, Inc. is seeking a Clinical Trial Associate in Hayward, CA to support the planning, execution, and operational management of global clinical trials.

You will collaborate with cross-functional teams, sites, investigators, CROs, sponsors, and vendors to ensure compliant, timely study conduct. The role emphasizes organization, proactive problem solving, and effective communication to manage multiple priorities in a fast-paced clinical development environment.

Qualifications

• Minimum 2 years of experience supporting clinical trials and coordinating site activities.
• Experience maintaining study documentation and data integrity.
• Knowledge of GCP, ICH guidelines, and regulatory inspections is preferred.
• Experience with CROs and clinical vendors is a plus.

Responsibilities

• 25% Study Operations & Site Management- Support planning, coordination, and day-to-day management of global trials; manage timelines, milestones, and site enrollment.
• 20% Documentation & eTMF Management- Maintain communications with sites and sponsors; support site management and enrollment tracking.
• 15% Quality, Compliance & Regulatory Support- Ensure GCP/GCLP/ICH compliance; support deviations and CAPA documentation; assist audits.
• 15% Data Management Support- Support collection, transfer, reconciliation, and secure storage of study data; track data queries.
• 15% Meeting Coordination & Tracking Tools- Coordinate study meetings, prepare agendas/minutes, track action items; maintain trackers and logs.
• 10% Budget, Financial & Risk Management- Support study budgets, POs, invoices, payments, and expense tracking.

Skills

Study coordination

GCP/GCLP knowledge

Documentation excellence

Communication skills

Cross-functional collaboration

Time management

Attention to detail

Education

Bachelor’s in biology or life sciences

CCR P/CCRA or advanced degree (optional)

Tools

eTMF systems

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Clinical Trial Associate

Full Time Hayward, CA, US

7 days ago Requisition ID: 1101

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:

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.

Predicine is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.