Clinical Trial Assistant
HighRidge Medical LLC
Summary
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.
Job description
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
- 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%
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).
- 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.
- 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
Company overview
HighRidge Medical LLC is a global medical device company specializing in innovative spinal solutions, established in 2024 and headquartered in Westminster, Colorado. As one of the world's largest privately held spine companies, HighRidge focuses on partnering with surgeons to drive innovation across the spectrum of spinal care. The company maintains a strong portfolio supported by extensive clinical evidence, offering solutions for complex spine procedures, motion preservation technologies, minimally invasive surgery (MIS), bone healing, and core spine applications. HighRidge Medical operates with a surgeon-focused approach, developing products that enhance surgical accuracy, streamline procedural workflows, and improve clinical outcomes. The company has demonstrated significant growth through strategic acquisitions, including assets from Accelus, and maintains distribution partnerships with companies like Osteotec. With approximately 1,001-5,000 employees globally, HighRidge serves patients worldwide while maintaining a commitment to value-based care and technological advancement in spinal surgery.