Sr Study Specialist

Job Title: Sr. Study Specialist, Global Study Operations Pay Rate: $55.00 – $61.50/hr Duration: 6-Month Contract Schedule: M-F 1st Shift!  Location: San Rafael, CA Summary The Sr. Study Specialist supports the planning, execution, and oversight of global clinical trials. This role partners with Study Managers and cross-functional teams to ensure studies are executed efficiently, compliantly, and on schedule. The position focuses heavily on vendor oversight, site coordination, documentation, and maintaining data integrity throughout the clinical trial lifecycle. Key Responsibilities Support and oversee clinical study operations from start-up through close-out Assist with site feasibility, selection, and site activation activities Oversee CROs and vendors for submissions, timelines, and deliverables Manage study documentation (TMF/eTMF) ensuring quality and inspection readiness Track study progress, timelines, and key performance metrics (KPIs) Support IRB/EC submissions and approvals Coordinate investigator training and assist with investigator meetings Maintain ClinicalTrials.gov entries and study updates Process documentation through DocuSign and manage approvals Identify risks and support mitigation strategies Participate in cross-functional and vendor meetings Qualifications Bachelor’s degree in Life Sciences, Health Sciences, or related field (or equivalent experience) Experience in biotech, pharma, or clinical research Experience managing vendors (CROs, labs, imaging vendors, etc.) Strong understanding of clinical trial lifecycle and compliance standards Experience with budgets, SOWs, POs, and invoice tracking Systems & Tools TMF/eTMF systems EDC (Electronic Data Capture) IRT/IXRS, eCOA/ePRO Microsoft Teams & SharePoint Benefits (employee contribution): Health insurance Health savings account Dental insurance Vision insurance Flexible spending accounts Life insurance Retirement plan All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. #IND0426

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