Clinical Project Specialist

Position Summary

The Clinical Project Specialist provides administrative and project coordination support across clinical studies and programs. This role supports the day to day execution of clinical trials by helping maintain study documentation, track study activities, coordinate meetings, support cross functional communication, and ensure deliverables are completed in line with SOPs, ICH GCP guidelines, and applicable regulatory requirements.

This is an ideal opportunity for a clinical operations professional with around 2 or more years of experience who is highly organized, detail oriented, collaborative, and comfortable supporting multiple projects in a remote environment.

Key Responsibilities

• Provide administrative and project support for the execution of clinical studies and related deliverables
• Assist with the preparation, formatting, review, and reconciliation of study specific documents and information
• Support day to day clinical trial operations in compliance with company SOPs, ICH GCP, and applicable regulatory requirements
• Collect, distribute, track, file, and maintain study documentation in accordance with internal processes and quality standards
• Assist with the development, assembly, and distribution of study materials, including site binders and other study related documents
• Track study specific information using databases, spreadsheets, trackers, and other systems and tools
• Support the tracking of study metrics, site activity, subject related information, supplies, and services as assigned
• Perform quality checks across study documentation, trackers, and operational components to support accuracy and completeness
• Schedule and coordinate project meetings, prepare agendas, capture meeting minutes, and distribute follow up actions
• Work closely with study teams and project leads to support assigned study execution activities and timelines
• Proactively identify issues, risks, or gaps related to assigned support activities and escalate as appropriate
• Contribute to process improvement, quality initiatives, and operational efficiency efforts within Clinical Operations
• Support additional project or departmental activities as needed

Required Qualifications

• 2 or more years of experience in a pharmaceutical, biotech, CRO, or clinical research environment
• Prior experience in a Clinical Project Specialist, Clinical Trial Assistant, Clinical Operations Coordinator, or similar support role
• Strong organizational skills with the ability to manage multiple tasks and deadlines with minimal supervision
• Strong written and verbal communication skills, with the ability to summarize information clearly and professionally
• Strong interpersonal skills and the ability to work effectively with cross functional teams and stakeholders at different levels
• Strong attention to detail and commitment to accuracy, documentation quality, and follow through
• Proficiency in Microsoft Office, including Outlook, Word, Excel, and PowerPoint
• Comfortable working with email, calendars, trackers, spreadsheets, and document management processes in a remote setting

Preferred Qualifications

• Bachelor’s degree preferred
• Equivalent relevant training and experience will also be considered
• Experience supporting clinical studies within a CRO, sponsor, or clinical research organization
• Familiarity with clinical systems such as EDC, CTMS, IVRS, and eTMF
• Experience supporting meeting coordination, document tracking, study team communications, and operational reporting
• Exposure to process improvement or quality related initiatives within Clinical Operations

Success Profile

The successful candidate will be:

• Highly organized and dependable
• Detail oriented and process driven
• Comfortable working independently in a fully remote environment
• Able to prioritize effectively across multiple studies and changing needs
• Collaborative, proactive, and solutions focused
• Confident handling administrative and coordination tasks that are critical to study execution

Why Join This Role

This position offers the opportunity to play a key support role in clinical trial delivery while working closely with experienced clinical operations professionals across multiple projects. It is well suited to someone looking to build further depth in clinical operations within a structured, remote, and project focused environment.