Clinical Trial Support Assistant

Work Location: Indianapolis, IN (onsite)

Work Hours: Monday - Friday, 8:00 am - 5:00 pm EST

Overtime: Occasional

Pay Rate: $22.00+ per hour

The Clinical Trial Support Assistant provides essential operational support to teams responsible for managing

investigation materials and clinical supply workflows. This role ensures that study‐related information, documents, and material status updates are accurately maintained and processed in a timely manner

Key Responsibilities:

Study Supply Data Management & Workflow Processing

• Input and update study supply information into approved databases with careful attention to accuracy and record integrity.

• Review incoming material‐related documents for completeness before organizing, storing, or forwarding them.

• Track incoming communications through shared inboxes and ensure requests or inquiries are directed to the appropriate

workflow or team member.

• Maintain electronic documents by uploading required files to designated systems and keeping audit‐ready organization.

• Follow up on pending supply actions or missing documentation to help keep study timelines on track.

Operational Coordination & Administrative Assistance

• Support the setup and maintenance of supply routing configurations and related operational tools under team guidance.

• Prepare and update supporting materials such as label references, distribution sheets, and other study‐specific documentation.

• Assist with the consolidation of documents and completion of designated tasks during clinical study closeout.

• Perform basic updates or status changes within study supply systems to ensure accurate operational data.

• Help maintain calendars or process schedules associated with depots, hubs, or assigned operational partners.

System Support & Resolution Coordination

• Review routine system alerts or incomplete process queues to identify items that require team attention.

• Document observations and gather relevant details to support troubleshooting by senior team members.

• Log system issues and track progress to ensure items are properly resolved and documented for quality oversight.

Reporting & Operations Insight Support

• Generate scheduled lists, extracts, and basic reports that assist in monitoring study supply activity and performance.

• Prepare organized data files or summaries used for operational planning and leadership updates.

• Confirm data accuracy and completeness before submitting information for analysis or decision‐making.

Material Lifecycle Monitoring & Documentation Maintenance

• Track lifecycle indicators such as upcoming retest reviews or documentation updates for investigation materials.

• Assist with preparing materials needed for lifecycle extensions or status changes.

• Maintain logs of extension‐related actions, label adjustments, and required documentation updates.

• Update system records promptly to ensure accurate reflection of product status across supply teams.

Team Collaboration, Training, & Professional Growth

• Work closely with team members to support shared operational goals and maintain consistent daily workflow coverage.

• Participate in training to develop familiarity with clinical supply systems, documentation requirements, and operational

processes.

• Take on additional tasks or project support responsibilities as knowledge and skill levels expand.

Requirements:
• Bachelors degree or equivalent experience
• Transportation knowledge
• Customs experience is a plus
• Must be detail oriented

Benefits:
KeyWords provides all its contingent workforce with:

• Medical, dental and vision benefits
• Paid time off (including sick and select holidays)
• 401(k) enrollment with 3% employer matching

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law

Role Information: EN

Studio: Keywords Studios

Location: Indianapolis, IN

Area of Work: DSS

Service: Clinical Trials

Employment Type: Contractor

Working Pattern: Full Time

This Organization Participates in E-Verify

Keywords Studios is committed to fair and ethical hiring practices. We expect candidates to conduct themselves with honesty and to participate in all applications and interviews independently, presenting their own knowledge and experience. Candidates should refrain from using AI assistance or third-party tools or services that could influence, capture, or otherwise interfere with the authenticity of the assessment process.