Clinical Research Assistant

About This Role

This Research Assistant position supports clinical trials by performing administrative tasks and assisting in clinical procedures to collect data on patients enrolled in studies. The role involves data verification, input into EDC and CTMS systems, and maintaining research files.

Responsibilities

• Verify and/or correct research study information on source documents
• Research queries and variances, and provide feedback to the site data collector
• Input research study data into trial Electronic Data Capture (EDC) system, maintaining quality control for content, accuracy, and completeness
• Prepare and maintain research study files
• Compile, collate and submit study information within established deadlines
• Assist in maintenance of regulatory documentation
• Schedule subject visits and generate appropriate reports and documents for research subjects prior to visits
• Input visit data into Clinical Trial Management System (CTMS) to track patient visits and procedures completed against the study budget
• Process required lab specimens, label vials, and accurately fill out requisitions for storage and/or shipment per study protocol and regulations

Requirements

• Ability to conduct patient chart reviews and determine eligibility
• Ability to support data entry and query resolution
• Basic knowledge of clinical trials
• In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study schedules
• Basic knowledge of medical terminology
• Skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word
• Excellent interpersonal skills

Qualifications

• BS/BA in life sciences or educational equivalent and/or relevant work experience in a clinical environment or medical setting
• Relevant work experience in a clinical environment or medical setting

Skills

* Required skills