Clinical Trial Specialist

Job Title: Sr. Study Specialist, Global Study Operations

Duration: 6-Month Contract (Potential to Extend/Convert)

Location: San Rafael, CA (Hybrid – Onsite Tuesdays & Thursdays)

Pay Rate: $54–56/hour

About the Company

A leading biotechnology organization focused on developing innovative therapies for patients with serious and life-threatening rare genetic diseases. The company is dedicated to advancing treatment options, improving patient outcomes, and supporting underserved patient populations globally.

Position Summary

The Sr. Study Specialist (SS) plays a critical role within Global Study Operations, supporting the execution and oversight of clinical trials. This individual will contribute to or lead key operational activities including site monitoring oversight, vendor management, and study execution support.

This role requires a strong understanding of the clinical trial lifecycle, the ability to manage complex operational tasks independently, and a focus on ensuring study quality, timelines, and compliance.

Key Responsibilities

• Develop and manage study-specific documentation in collaboration with Study Managers
• Support feasibility assessments, site selection, and site start-up activities
• Oversee CRO activities, including IRB/EC submissions and approvals
• Manage essential documents throughout the study lifecycle (TMF/eTMF)
• Develop and oversee site and investigator training materials
• Participate in and present at investigator meetings as needed
• Ensure accuracy and timeliness of study-related data and documentation
• Oversee Clinical Trial Insurance activities
• Manage updates to ClinicalTrials.gov
• Track Screening Authorization Forms and study-related documentation
• Facilitate document execution through DocuSign
• Identify study risks and support mitigation strategies
• Participate in cross-functional, vendor, and study execution meetings
• Provide administrative and operational support for internal and external meetings

Technical Competencies

• Clinical study management and execution
• Compliance, quality, and inspection readiness
• Drug development and clinical study design understanding
• Therapeutic area and product knowledge

Systems & Tools

• TMF/eTMF systems (quality and inspection readiness)
• EDC systems (operational workflows and timelines)
• IRT/IXRS and eCOA/ePRO platforms
• Vendor and site tracking tools (KPIs, milestones)
• Microsoft Teams and SharePoint
• Strong focus on data integrity and system accuracy

Qualifications

• Bachelor's degree in life sciences, nursing, or related field (or equivalent experience)
• Experience in biotech or pharmaceutical industry
• Experience managing external vendors (CROs, labs, imaging vendors, etc.)
• Familiarity with budgets, SOWs, POs, and invoice management
• Strong understanding of clinical trial lifecycle (start-up through close-out)
• Ability to work independently in a fast-paced, complex environment

Please submit your resume in Word or PDF format to be considered.