Job Title: Clinical Trial Specialist

Work Location: REMOTE

Summary:

The Clinical Trial Specialist is responsible for providing logistical support for clinical trials, collaborating with cross-functional teams to ensure all trial activities from site start-up to close-out are conducted in compliance with Standard Operating Procedures and applicable regulations.

Responsibilities:

• Develop, review, and maintain essential study documents, including site instructions, informed consent forms, lab manuals, and study plans.
• Set up and manage trackers, tools, dashboards, and reports to monitor study metrics and support clinical trial operations.
• Manage small-scope vendors and assist with oversight of more complex vendors as needed.
• Oversee vendor contracts, including handling invoicing, purchase order monitoring, and forecasting with guidance from study leads.
• Perform site management responsibilities as assigned to ensure smooth trial execution.
• File and maintain study documents in the electronic Trial Master File, coordinate document lists, participate in completeness reviews, and serve as a contact for records management.
• Contribute content and updates to team meetings, including those focused on study management.
• Collaborate with internal teams to ensure compliance with regulatory requirements and support overall clinical trial success.

Qualifications:

• Bachelor’s degree or equivalent required; scientific or healthcare discipline preferred.
• Minimum of two years of direct work experience in clinical research.
• Understanding of clinical study phases and general knowledge of clinical development processes.
• Ability to manage multiple tasks and deadlines, identify issues, and take appropriate actions.
• Self-motivated with the ability to work on moderately complex problems requiring analysis of various factors.
• Strong interpersonal skills to build and maintain positive relationships with management and peers.
• Willingness to travel up to 10% as required.

Published Category: Clinical Operations & Development