Clinical Research Data & Compliance Coordinator I

Washington University in St. Louis; United States; On-site; USD 49,000 - 74,000; Full time

Job summary

Washington University in St. Louis is seeking a data coordinator to support clinical research trials by extracting data from EMR and other sources, then entering it into an electronic data capture system.

You will manage data for multiple trials, ensuring protocol requirements are met and patient safety and data integrity are upheld. You will collaborate with investigators, sponsors, and vendors, assisting with IRB documents, study start-up activities, subject enrollment, and data quality

Qualifications

• Bachelor's degree or combination of education and/or experience may substitute for minimum education.
• Basic Life Support certification must be obtained within one month of hire date.
• SOCRA/ACRP certification (optional based on Department)

Responsibilities

• Works under the PI's guidance to meet the project objectives.
• Assists with study start-up activities including IRB applications for initial review and reportable events.
• Identifies, screens, and enrolls study subjects with the research team.
• Ensures protocol requirements are met: contact with participants, health data collection, procedures coordination, specimen handling, and data entry.
• Prepares and submits reportable event reports to sponsors and IRB per protocol and policies.
• Collaborates with sponsor research associates during monitoring with documentation and reports.
• Performs other duties incidental to the work described.

Skills

Clinical Research

Clinical Study Protocols

Communication

Computer Systems

Interpersonal Communication

Organizing

Research Support

Education

Bachelor's degree

Job description

Washington University in St. Louis is seeking a data coordinator to support clinical research trials by extracting data from EMR and other sources, then entering it into an electronic data capture system.

You will manage data for multiple trials, ensuring protocol requirements are met and patient safety and data integrity are upheld. You will collaborate with investigators, sponsors, and vendors, assisting with IRB documents, study start-up activities, subject enrollment, and data quality