Clinical Trial Assistant: eTMF & Study Operations

Highridge Medical LLC; Westminster (CO); On-site; USD 68,000 - 75,000; Full time

Job summary

Highridge Medical LLC is seeking a Clinical Trial Assistant to support the Clinical Affairs team in sponsored studies. You will maintain the eTMF, support study operations, vendor management, and site payments to keep records inspection-ready.

The ideal candidate has a life sciences degree or equivalent, 1 year of clinical research experience, familiar with GCP, and proficiency in Microsoft Office, SharePoint, and OpenClinica. Travel 0% and salary $68,000-$75,000 plus DOE.

Qualifications

• Bachelor's degree in life sciences, health sciences, or related field.
• At least 1 year of clinical research experience.
• Experience maintaining a TMF or regulatory binder.
• Familiarity with GCP and 21 CFR Part 812 is preferred.

Responsibilities

• Maintain the eTMF and site essential documents to keep study records inspection ready.
• Support day-to-day study operations including site start-up and IRB submissions.
• Coordinate trial material shipments and vendor management activities.
• Assist with IRB audit preparation and study trackers for enrollment and site status.

Skills

Attention to detail

Organization

Communication

Discretion with confidential info

Grow into CRA role

Education

Bachelor's degree in life sciences or related field

Equivalent experience

Tools

SharePoint

OpenClinica

Microsoft Excel

MS Office

Job description

Highridge Medical LLC is seeking a Clinical Trial Assistant to support the Clinical Affairs team in sponsored studies. You will maintain the eTMF, support study operations, vendor management, and site payments to keep records inspection-ready.

The ideal candidate has a life sciences degree or equivalent, 1 year of clinical research experience, familiar with GCP, and proficiency in Microsoft Office, SharePoint, and OpenClinica. Travel 0% and salary $68,000-$75,000 plus DOE.