Sr Study Specialist

Job Title: Sr Study Specialist


Location: San Rafael, CA


Type: Contract


Compensation: $50 - $58/hour


Contractor Work Model: Hybrid


Hours: 40.0

Responsibilities

• Oversee various aspects of clinical study management, including documentation development, site and country feasibility assessments, regulatory submissions, and study lifecycle oversight
• Develop study-specific documentation as delegated by the Study Manager
• Contribute to the oversight of country and site feasibility assessment and site selection
• Oversee CRO activities related to IRB/EC submission and approval processes
• Manage essential documents throughout the study lifecycle
• Develop and oversee site and investigator training materials
• Present at investigator meetings as assigned
• Ensure accurate and timely oversight of Clinical Trial Insurance
• Attend Global Study Operations team, vendor, and cross-functional study meetings
• Oversee and manage study entry and updates to ClinicalTrials.gov
• Facilitate Screening Authorization Forms sign-off and tracking
• Process documents for signature in DocuSign
• Contribute to risk identification and mitigation strategies in Global Study Operations
• Provide support and administrative assistance for internal and external meetings
• Support end-to-end study operations across startup, maintenance, and closeout activities in a fast-paced, complex clinical trial environment
• Maintain proficient understanding of clinical trial lifecycle milestones, critical path dependencies, and inspection readiness
• Work independently in complex operational workstreams with minimal oversight
• Utilize core clinical systems including TMF/eTMF, EDC, IRT/IXRS, and eCOA/ePRO platforms
• Track vendor milestones, site activities, and KPIs with system accuracy and data integrity

Requirements

• BA/BS or higher in nursing, life or health sciences preferred; relevant industry experience considered in lieu of education
• Experience in biotechnology or pharmaceutical industry, including oversight of external vendors (CROs, labs, imaging, etc.)
• Proficiency with clinical systems such as TMF/eTMF, EDC, IRT/IXRS, and eCOA/ePRO platforms
• Strong organizational skills with attention to detail and data integrity
• Excellent communication and collaboration skills
• Ability to work independently in a fast-paced, complex environment

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical