Clinical Trial Specialist Jobs

About The Position

Requirements

• Bachelor’s degree in Life Sciences, Nursing, or a related scientific discipline.
• At least 4–6 years of experience supporting clinical trials in the biotechnology, pharmaceutical, or CRO industry, with demonstrated experience coordinating multiple clinical studies.
• Working knowledge of ICH GCPs and applicable international regulations governing clinical research.
• Proficiency with Microsoft Office Suite.
• Strong interpersonal, written, and verbal communication skills.
• Excellent organizational skills, strong attention to detail, and the ability to manage multiple priorities in a fast-paced environment.
• Ability to work as part of a multifunctional, cross-functional study team while independently managing assigned responsibilities.
• Must be based in the San Francisco Bay Area.

Nice To Haves

• Experience with eTMF, CTMS, or other clinical systems.

Responsibilities

• Independently coordinate and maintain accurate, current study status information, trackers, and operational metrics for assigned clinical studies.
• Develop, maintain, and continuously improve tracking systems, forms, and other documents that support clinical studies.
• Prepare and maintain study trackers, spreadsheets, presentations, and other operational documents using Microsoft Office Suite.
• Perform routine quality reviews of the eTMF to ensure completeness, accuracy, and ongoing inspection readiness.
• Maintain and organize electronic clinical trial documents and ensure timely filing of essential documents in the eTMF.
• Coordinate collection, review, and tracking of essential study documents from study sites, CROs, and vendors to support study milestones and inspection readiness.
• Coordinate logistics for clinical operations team meetings and kick-off meetings; prepare agendas, draft minutes, track action items, and follow up on outstanding deliverables.
• Assist with tracking clinical lab samples for multiple clinical trials, including shipments from lab vendors, documentation of reconciliation practices, and follow-up on outstanding items.
• Support study start-up, maintenance, protocol amendment implementation, and closeout activities as assigned.
• Partner with cross-functional teams, including Clinical Supply, Data Management, Regulatory Affairs, Quality Assurance, and Medical Monitoring, to support operational study deliverables.
• Support departmental process improvement initiatives.

Benefits

• Flexible work schedules.
• Remote work opportunities.
• Shuttle service from BART, CalTrain, and the Ferry.
• Competitive base salary and equity participation.
• Employee stock purchase plan.
• Comprehensive health benefits, including medical, dental, and vision insurance.
• 401(k).
• Flexible spending plans.
• Other benefits.