Tracie Baker Email and Phone Number

Job Duties:• Monitor the conduct of UAMS-sponsored investigator- initiated IND and IDE clinical trials• Verify subject safety and site adherence to FDA Regulations, H/GCP Guidelines, IRB policies, and institutional policies.• Ensure Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.• Review source documentation, CRFs, Informed Consent Documents• Acquire specific clinical and therapeutic knowledge related to studies monitored. • Conduct Initiation, Interim, and Closeout monitoring visits.• Ensure complete and thorough study drug reconciliation. • Write monitoring reports, letters, and query resolutions.• Manage site master file contents and work with sites to ensure communication requirements between site and IRB are adhered to.• Maintain the sponsor trial master for each IND/IDE study• Provide support and timely follow-up for all audit and quality assurance activities• Develop all monitoring tools needed for monitoring specialists. This includes adverse event databases, visit checklists, drug accountability spreadsheets, CRF Tracking tools• Assist in the development of an in-house electronic data capture system and subject registry.• Develop CRFs for each IND/IDE study we monitor • Develop the monitoring plan for each IND/IDE study• Train coordinators, investigators, and other study staff in CRF/source documentation completion and adverse event reporting.• Hire and train monitoring specialists.

Job Duties:• Monitor the conduct of UAMS-sponsored investigator- initiated IND and IDE clinical trials• Verify subject safety and site adherence to FDA Regulations, H/GCP Guidelines, IRB policies, and institutional policies.• Ensure Adverse Events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary.• Review source documentation, CRFs, Informed Consent Documents• Acquire specific clinical and therapeutic knowledge related to studies monitored. • Conduct Initiation, Interim, and Closeout monitoring visits.• Ensure complete and thorough study drug reconciliation. • Write monitoring reports, letters, and query resolutions.• Manage site master file contents and work with sites to ensure communication requirements between site and IRB are adhered to.• Develop some monitoring tools needed for monitoring specialists. This includes adverse event databases, visit checklists, drug accountability spreadsheets, CRF Tracking tools• Assist in the development of an in-house electronic data capture system and subject registry.• Assist in the development of CRFs for each IND/IDE study we monitor

Job Duties:• Subject Recruitment• Subject scheduling• IRB Submissions• Specimen processing and shipping• Case Report Forms Completion and query resolution• Conducting Informed Consent• SAE Reporting• Maintain Regulatory Files