Clinical Trial Associate

Predicine, Inc • Hayward, CA

10d • Onsite

About The Position

The Clinical Trial Associate supports the planning, execution, and operational management of global clinical trials. Reporting to the Associate Director, Clinical Development, the role works with internal cross-functional teams, clinical sites, investigators, CROs, sponsors, and external vendors to help ensure studies are conducted efficiently, accurately, and in compliance with applicable regulations and company procedures. The position is onsite in Hayward, California, within the Clinical Development department, and is full-time.

The role supports studies from start-up through close-out, including site and timeline coordination, eTMF and study documentation, quality and regulatory activities, study data processes, meeting coordination, tracking tools, budgets, and risk management. The ideal candidate is organized, detail-oriented, proactive, adaptable, communicative, and able to manage multiple priorities in a fast-paced clinical development environment.

Requirements

• At least 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 terminology.
• 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.
• Strong attention to detail and organizational skills, with the 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.
• Bachelor’s degree in biology, Life Sciences, or a related field required; an associate degree in a health science field may be considered with relevant clinical trial experience.

Nice To Haves

• Experience with laboratory-related clinical studies or diagnostic product development.
• An advanced degree or relevant certification, such as CCRP or CCRA.

Responsibilities

• Support planning, coordination, and day-to-day management of global trials from start-up through close-out.
• Manage study timelines, milestones, and deliverables; track site enrollment, outstanding documents, site questions, and action items; and maintain communication with sites, investigators, sponsors, and vendors.
• Maintain study documentation and eTMF records, and support site management activities.
• Support GCP/GCLP/ICH compliance; document protocol deviations and CAPAs; collaborate with Quality Assurance and Regulatory Affairs; and 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 and minutes, track action items, and maintain trackers, project plans, contact lists, and issue logs.
• Support study budgets, purchase orders, invoices, payments, and expense tracking.
• Identify study risks or delays and support root-cause analysis.

What This Job Offers

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