Clinical Research Coordinator I (Data) - Neurology

Position Summary

Assists investigators as a data coordinator of clinical research trials of all complexities, extracting data from the Electronic Medical Record (EMR) and other source documents and entering it into an Electronic Data Capture (EDC). May be responsible for numerous research trials simultaneously. Helps ensure the accurate collection of study- required procedures while patients are receiving protocol treatment and are in active protocol follow-up.

Primary Duties & Responsibilities

• Works under the Principal Investigator’s (PI) guidance to meet the research objectives of the project.
• Assists with study start-up activities including IRB applications for initial review, modifications/amendments, continuing reviews, and reportable events.
• Works with research team to identify, screen, and enroll study subjects.
• Ensures protocol requirements are met, including but not limited to: direct contact with research participants; collection of basic health information; coordination of study related procedures; handling, processing, and shipping of research specimens; organization of source documentation and data entry.
• Prepares/submits reportable event reports to sponsor(s), IRB and regulatory agencies in accordance with the study protocol and established policies, procedures, and regulations.
• Collaborates with sponsor’s research associates during monitoring activities by providing study documentation, data clarifications, and reports, as necessary.
• Performs other duties incidental to the work described above.

Required Qualifications

Education: Bachelor’s degree or combination of education and/or experience may substitute for minimum education.

Certifications/Professional Licenses: Basic Life Support - American Heart Association, Basic Life Support - American Red Cross

Work Experience: No specific work experience is required for this position.