Clinical Trial Specialist

Clinical Trial Specialist (CTS)Job Description: The Clinical Trial Specialist (CTS) provides operational and administrative support to the Clinical Operations team to support the successful execution of clinical trials across multiple phases. This role works closely with Clinical Trial Managers, CROs, vendors, and investigational sites to support study activities and maintain accurate, inspection-ready documentation in compliance with ICH-GCP and regulatory requirements.Key Responsibilities:Provide operational support for multiple clinical trials from start-up through close-out.Create, review, and maintain study documents, trackers, and communications.Maintain Trial Master File (TMF/eTMF) documentation, ensuring accuracy, completeness, and version control.Collect and review essential and regulatory documents from sites, CROs, and vendors.Support site activation and regulatory submission activities.Coordinate communications with study teams, CROs, and investigational sites.Schedule study meetings and document key outcomes.Support audit and inspection readiness activities.Maintain accurate data tracking within clinical systems (e.g., CTMS, eTMF, EDC).Assist with vendor coordination, invoice tracking, and general study support.Ensure compliance with applicable regulations, SOPs, and study plans.Required Qualifications:Bachelor’s degree in life sciences, health sciences, or related field (or equivalent experience).2–4 years of clinical trial or clinical operations experience.Working knowledge of clinical trial processes and ICH-GCP guidelines.Experience supporting CROs, vendors, and investigational sites.Strong organizational, communication, and time management skills.Proficiency in Microsoft Office.