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Sr Study Specialist

System One • San Rafael, CA • 2h ago

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

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.

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