Clinical Support Specialist – Regulatory & Site Activation (Hybrid)

About the role

The Clinical Support Specialist provides operational and administrative support to multiple clinical functions, ensuring smooth project execution and compliance with regulatory and site activation processes.

Key responsibilities

• Coordinate documentation and communications, manage shared mailboxes, organize project files, and track action items with cross‑functional stakeholders.
• Enter, maintain, and reconcile data in project and clinical tracking systems, including timeline and milestone tracking.
• Perform document management activities such as creation, formatting, version control, quality control, and support Trial Master File (TMF) filing.
• Utilize AI‑enabled tools, dashboards, and automated reports to provide logistical, organizational, and analytical support.
• Monitor workload, budgeted effort, and project hours; escalate discrepancies and ensure compliance with SOPs, work instructions, and training requirements.

Required profile

• Associate’s degree or equivalent combination of education and experience.
• Minimum 1 year of clinical operations experience with a solid understanding of clinical research processes.
• Strong documentation and communication skills in written and spoken English.
• Ability to manage competing priorities in a fast‑paced, dynamic environment.

Required skills

• Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, Publisher).
• Experience using AI‑enabled tools, dashboards, and automated reporting systems.
• Document management, version control, and quality‑control procedures.