Summary

The Department of Medicine, Section of Gastroenterology & Hepatology, is looking to hire an competent and reliable Senior Coordinator, Clinical Research to manage day to day operations of the Dr. Hou's research mission, supporting largely an NIH funded PCORI grant award. The candidate will assist with study management of this award, collecting information, maintain IRB compliance regulations and will work directly with the PI. The position requires excellent leadership skills, collaboration, and ability to advance the section's research mission.

Job Duties

• Oversees site operations - Performs study coordination/research quality evaluation, including regulatory document control, ensuring protocol compliance and subject safety, monitoring data entry, and ensuring that all sites complete reporting requirements
• Manages trial master file (TMF) for study
• Completes submission of amendments in BRAIN and acts as direct liaison to local Institutional Review Board (IRB) regarding study submissions
• Ensures validity, completeness, and correctness of clinical data collected
• Develops protocol amendments, informed consent, manual of operations, and data instruments for amendment packages for consortium
• Develops maintenance of processing and tracking systems for regulatory documents, subject follow-up outstanding queries, etc.
• Completes annual progress reports for grant renewal
• Tracksmilestones and progress of study deliverables
• Manages membership, meeting minutes, and communications for consortium
• Approves patient compensation for local study sites
• Generates reports to be used for invoicing sponsors
• Implements changes in protocols in order to ensure that study needs are being met effective

Minimum Qualifications

• High School diploma or GED.
• Four years of relevant experience.