Clinical Trial Assistant
Deerfield , IL
The Clinical Trial Assistant (CTA) will support the clinical project teams in the following areas: accurately update and maintain clinical systems within project timelines; prepare, handle, distribute, file, and archive clinical documentation and reports including maintaining clinical trial management systems (CTMS);; prepare, handle, and distribute clinical trial supplies (other than test article); and maintain relevant tracking information;. The CTA may act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation. The CTA may contact clinical trial sites via phone, fax, and email as needed. The CTA will perform administrative tasks to support team members with clinical trial execution as needed. This role functions as in-house support staff member for clinical trials.
- Follow applicable Standard Operation Procedures (SOPs)
- Assist with the creation and maintenance of documentation for given clinical studies including but not limited to: training materials, operations/regulatory/pharmacy/other binders, monitoring plans, presentations, reports, and journal articles.
- Submit applicable documents to the Trial Master File (TMF). Under the supervision of the PM or designee. Under the supervision of the PM, assist with maintenance of tracking tools of clinical studies. Produces reports from tracking systems as required.
- Responsible for accurate distribution of all clinical trial related materials (other than test article) to clinical trial sites or clinical team/CRA members.
- Requests SharePoint (or other Enterprise-level system) user access and manages project level file structure within the system.
- Manages and maintains user assignments for electronic data capture (EDC) and/or interactive web-response systems (IWRS) or interactive voice-response systems (IVRS) as per project specifications.
- Assist CRA(s) in preparation for clinical trial site monitoring visits.
- May interact with external contacts to assist in management of vendors.
- Assist in the creation of study materials, presentations, and other materials based on existing templates.
- Assist with the preparation of agenda, meeting minutes, and action item tracking.
- High school diploma/certificate or educational equivalent; BS/BA preferred;
- Strong computer and software skills including proficiency in use of Microsoft Word, Excel, Outlook, Project, PowerPoint and Adobe Acrobat.
This job description is a summary of the job and requirements that are essential to the performance of the job. It is not intended to be complete in detail. Individuals classified in the job are required to perform the expectations for the specific job, which may, on occasion, include functions of a higher or lower skill level than is included in this classification.