Clinical Trial Assistant

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%

· 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.