Clinical Trial Assistant

HIGHRIDGE Inc.; Westminster (CO); On-site; USD 68,000 - 75,000; Full time

Job summary

Highridge Medical is seeking a Clinical Trial Assistant to support the Clinical Affairs team in conducting sponsored clinical studies. You will manage the electronic Trial Master File (eTMF), maintain site documents, and assist with site start-up, IRB submissions, and audits.

Ideal candidates have a life sciences degree, at least 1 year of clinical research experience, and proficiency with SharePoint and OpenClinica.

Qualifications

• Bachelor’s degree in life sciences or related field, or equivalent experience.
• At least 1 year of clinical research experience.
• Experience maintaining TMF or site regulatory binder.
• Working knowledge of GCP.
• Proficiency in Microsoft Office, especially Excel.
• Medical device clinical research experience.
• Familiarity with 21 CFR Part 812 and ISO 14155.
• Experience with SharePoint and OpenClinica or similar EDC.
• Experience with invoices or purchase orders.

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 (IRB approvals, consent versions, CVs, training records).
• Track document expirations and renewals from sites.
• Maintain study trackers for site status, enrollment, and IRB submissions.
• 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.

Skills

GCP

Excel

Discretion with confidential info

Written/verbal communication

Education

Bachelor’s degree in life sciences

Tools

SharePoint

OpenClinica

Job description

Clinical Trial Assistant

Highridge Medical creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation to Minimally Invasive Surgery to Core Spine.

Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents to demonstrate Confidence in your work and restore Confidence for our patients. Confidence that moves.

Clinical Trial Assistant Role

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

Key Responsibilities

• Trial Master File and Study Documentation
• 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, such as IRB approvals, consent versions, CVs, and training records.
• Track document expirations and request renewals from sites.

Clinical Study Support

• 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.

Departmental Operations Support

• Support vendor management and site payment activities.
• Work with Finance and other internal teams on departmental operational needs.
• Perform other duties as assigned.

Qualifications

Required

• 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).
• Proficiency in Microsoft Office, especially Excel preferred
• 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.

Skills and Competencies

• Strong attention to detail
• Strong organization and follow-through
• Clear written and verbal communication
• Discretion with confidential information
• Interest in growing into a CRA role

Travel

0%

Salary Range

Salary Range: $68,000- $75,000.00 +Bonus DOE