Research Coordinator II

• Jan 2019 - Present

Regulatory Coordinator

• Jul 2017 - Jan 2019

Successfully coordinate all regulatory functions for drug and device studies conducted through Palmetto Health such as IRB submissions, Internal Administrative Review submissions and sponsor submissions. Conduct internal quality reviews, maintain CTMS, assist in writing Standard Operating Procedures, participate in study feasibility assessments and manage regulatory start up activities.

Research Budget Specialist

• Apr 2016 - Jul 2017

Coordinate the budget process in collaboration with Principal Investigators, legal, clinical departments/ancillary services, and sponsors/granting agencies. •Interpret the financial requirements and billable nature of items and services for research protocols by performing a comprehensive coverage analysis to ensure accurate determinations of research patient care billing. •Develop initial and revisionary research budgets to ensure adequate coverage of study costs. •Negotiate… Show more Coordinate the budget process in collaboration with Principal Investigators, legal, clinical departments/ancillary services, and sponsors/granting agencies. •Interpret the financial requirements and billable nature of items and services for research protocols by performing a comprehensive coverage analysis to ensure accurate determinations of research patient care billing. •Develop initial and revisionary research budgets to ensure adequate coverage of study costs. •Negotiate and finalize study budgets for studies on behalf of Palmetto Health and the Principal Investigators. •Submit requests to the Medicare program for approval of appropriate device studies and humanitarian use devices. •Ensure budgetary compliance with federal regulations and other funding source stipulations.

Regulatory Affairs Manager and Audit/Quality Assurance Coordinator

• 2001 - 2003

Regulatory Affairs Manager: Facilitated regulatory compliance between Investigators, Sponsors, Cooperative Groups, Institutional Review Boards, Research Privacy Board, Research Nurses, Participating Sites, National Cancer Institute and Food and Drug Administration •Coordinated all regulatory functions for the Phase II Network and Phase I Trials •Submitted FDA IND applications and annual reports Audit/Quality Assurance Coordinator Developed, implemented and maintained a system… Show more Regulatory Affairs Manager: Facilitated regulatory compliance between Investigators, Sponsors, Cooperative Groups, Institutional Review Boards, Research Privacy Board, Research Nurses, Participating Sites, National Cancer Institute and Food and Drug Administration •Coordinated all regulatory functions for the Phase II Network and Phase I Trials •Submitted FDA IND applications and annual reports Audit/Quality Assurance Coordinator Developed, implemented and maintained a system for the reporting of adverse events and safety reports for all trials conducted through the University of Chicago Cancer Center •Coordinated compliance for all Phase II Network trials •Managed the Phase II Network participant site audits (includes audit scheduling, on-site auditing, reporting and follow-up) •Compiled safety data for periodic Data Safety Monitoring meetings •Served on the University of Chicago Cancer Center Institutional Review Board Show less Regulatory Affairs Manager: Facilitated regulatory compliance between Investigators, Sponsors, Cooperative Groups, Institutional Review Boards, Research Privacy Board, Research Nurses, Participating Sites, National Cancer Institute and Food and Drug Administration •Coordinated all regulatory functions for the Phase II Network and Phase I Trials •Submitted FDA IND applications and annual reports Audit/Quality Assurance Coordinator Developed, implemented and maintained a system… Show more Regulatory Affairs Manager: Facilitated regulatory compliance between Investigators, Sponsors, Cooperative Groups, Institutional Review Boards, Research Privacy Board, Research Nurses, Participating Sites, National Cancer Institute and Food and Drug Administration •Coordinated all regulatory functions for the Phase II Network and Phase I Trials •Submitted FDA IND applications and annual reports Audit/Quality Assurance Coordinator Developed, implemented and maintained a system for the reporting of adverse events and safety reports for all trials conducted through the University of Chicago Cancer Center •Coordinated compliance for all Phase II Network trials •Managed the Phase II Network participant site audits (includes audit scheduling, on-site auditing, reporting and follow-up) •Compiled safety data for periodic Data Safety Monitoring meetings •Served on the University of Chicago Cancer Center Institutional Review Board Show less