Job Details

Job Requirements

Position Summary

The Clinical Research Associate will work closely with research coordinators and research staff. Responsible for Clinical Research Data Management. Coordinate the data flow and submission for clinical research trials in an organized and timely manner. Establishing and following procedures for effectively gathering, extracting, and entering data including hard copy and electronic file management for clinical research.

Minimum Requirements

Education
• High School Diploma or Equivalent Education

Experience
• Two (2) years medical secretary, tumor registry, medical assistant or research assistant experience



License/Registration/Certifications
• N/A



Preferred Requirements

Preferred Education
• Associate or bachelor's Degree

Preferred Experience
• Research Assistant Experience



Preferred License/Registration/Certifications


• N/A

Core Job Responsibilities

• Provide support to research nurses and coordinators by preparing research charts, performing database searches, and assisting with reports.
• Coordinate with clinical research staff to accurately collect and record clinical research data.
• Electronic Data Capture (EDC) entry and query management required.
• Data extraction from Electronic Health Record (EHR) for purposes of data entry in required Case Report Forms (CFR) or EDCs.
• Knowledge and access to multiple electronic data capture systems for data entry including Clinical Trial Management System (CTMS).
• Research specimen handling and shipping required.
• Collect patient outcomes for follow-up via EHR review or direct communication with patient as required.
• Attend Site Initiation Visits.
• Basic knowledge of FDA regulations.
• Must be meticulous with detail.
• Must be able to read, write, and speak English fluently.
• Must have good communication skills.
• Must be able to respond calmly and efficiently in high stress situations.
• Must be able to sit for long periods of time, filling out paperwork.
• Must be self-directed and able to work without supervisor.