Clinical Research Coordinator I Vanderbilt Health

Overview

Responsible for coordinating approval processes and conduct of research protocols while maintaining integrity and quality of clinical research. Prepare and process new IRB research proposals amendments continuing review applications and adverse event reports. Maintain documents required for internal regulatory and sponsor access. Perform site visits to review research and source documentation. Procure equipment and supplies. Record data onto case report forms. Attend queries promptly. Ensure compliance with regulations and good clinical practice. Package and ship specimens following guidelines. Assist with study completion closeout and archiving. Develop and manage study budgets. Advocate for human subjects through communication with investigators and participants. Determine eligible candidates assessing medical history. Communicate positively with participants and coworkers. Perform or instruct others in protocol procedures. Report deviations to PI. Provide support to research faculty and staff.

What You'll Do16

• 1Assist in preparing and processing new IRB research proposals amendments continuing review applications and adverse event reports according to institutional and departmental policies and federal regulations
• 2Prepare and maintain documents required for internal regulatory and sponsor access prior to during and after clinical trials
• 3Participate in periodic site visits from sponsor regulatory authorities to review research source documentation and procedures
• 4Procure equipment and supplies needed to fulfill project requirements
• 5Record data from source documentation and participant interaction onto case report forms with awareness of accuracy completeness and timeliness
• 6Attend to query resolution in a timely manner
• 7Ensure research information is collected and stored in a manner that complies with regulations and good clinical practice
• 8Package and ship study specimens blood urine etc. to sponsor or laboratory following guidelines
• 9With direction assist with study completion study closeout and archiving of study files
• 10Perform ongoing checks of clinical translational data entered on case report forms or reports
• 11Develop and manage study budgets monitoring efficient invoicing and maintaining billing compliance
• 12Advocate for human subjects by establishing communication with investigators research staff sponsors participants and professional organization representatives
• 13Participate in determining eligible candidates for study participation assessing medical historical information to ensure appropriate enrollment
• 14Engage in open communication with study participants and coworkers
• 15Perform or instruct others in protocol procedures deviating only when subject safety is at risk and report deviations to principal investigator
• 16Collaborate with research faculty and staff across disciplines

Salary Insight