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Clinical Study Specialist

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Insight Global

Irvine, CA (In Person)

Full-Time

Posted 1 week ago (Updated 16 hours ago) • Actively hiring

Expires 7/12/2026

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Job Description

Job Description The Clinical Research Specialist wil support the execution of clinical trials by ensuring compliance with study timelines, regulatory requirements, and internal procedures. This role serves as a key point of contact for clinical trial sites, providing ongoing site management support and assisting with issue resolution. The specialist supports clinical data review activities, including helping sites resolve queries and ensuring data accuracy and completeness. Responsibilities include reviewing trip reports, tracking follow-up actions, and maintaining clear documentation across study activities. The role also involves performing data entry and managing essential documents within VTMF and CTMF systems to ensure inspection readiness. Additionally, the specialist collaborates cross-functionally with CRAs, sites, and internal stakeholders to support study operations and maintain high-quality trial execution. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.

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Insight Global's Workforce Privacy Policy:
https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements Bachelor's degree in Life Sciences, Clinical Research, Nursing, Public Health, or a related field. 2+ years of experience supporting clinical research studies or clinical trial operations. Hands-on experience with site management and site-facing clinical support. Experience assisting in clinical data review and supporting data cleaning activities. Experience helping sites work through query resolution. Experience reviewing trip reports and tracking follow-up actions. Experience with data entry and document management in VTMF and CTMF tools.