Job Information
System One Sr Study Specialist in San Rafael, California
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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System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services 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 full-time 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.