Clinical Trial Support Assistant

Keywords Studios•Indianapolis, IN

5d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Customs experience is a plus

Responsibilities

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.
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.
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.
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.
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.
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.