Clinical Trial Assistant

Highridge Medical•Westminster, CO

1d•$68,000 - $75,000

About The Position

The Clinical Trial Assistant (CTA) supports the Clinical Affairs team in conducting sponsored clinical studies. The role maintains the electronic Trial Master File and site essential documents, ensuring study records are complete and inspection ready. The CTA also supports day-to-day study operations, including study tracking, site start-up, IRB submissions, audit preparation, vendor management, site payments, and other departmental operations as needed.

Requirements

Bachelor's degree in life sciences, health sciences, or a related field, or equivalent experience.
At least 1 year of clinical research experience.
Experience maintaining a TMF or site regulatory binder.
Working knowledge of Good Clinical Practice (GCP).
Medical device clinical research experience.
Familiarity with 21 CFR Part 812 and ISO 14155.
Experience with SharePoint and OpenClinica or a similar EDC.
Experience with invoices or purchase orders.
Strong attention to detail.
Strong organization and follow-through.
Clear written and verbal communication.
Discretion with confidential information.

Nice To Haves

Proficiency in Microsoft Office, especially Excel.
Interest in growing into a CRA role.

Responsibilities

Maintain the electronic Trial Master File (eTMF) in SharePoint for sponsored studies, including the IDE study.
File, index, and quality-check essential documents.
Perform periodic TMF reviews and keep the TMF inspection ready.
Collect and track site essential documents, including IRB approvals, consent versions, CVs, and training records.
Track document expirations and request renewals from sites.
Maintain study trackers for site status, enrollment, and IRB submissions.
Support site start-up document collection.
Coordinate trial material shipments and returns.
Support EDC query tracking in OpenClinica.
Take notes at study team meetings and track action items.
Support IRB submissions and audit preparation as directed.
Support vendor management and site payment activities.
Work with Finance and other internal teams on departmental operational needs.
Perform other duties as assigned.