Amanda Epperson Email & Phone Number

Greater Memphis Area

• Responsible for hiring and training Project Manager staff and ancillary staff• Performance evaluations (mid-year and end of year) for staff• Manage staff resourcing, PTO, and timesheets• Manage disciplinary issues with staff and HR• Work closely with the sponsor, investigator, and appropriate staff in each department including, data management, IT, regulatory, quality assurance, contracts and budgets, medical writer, central pharmacy, and biostatisticians to complete projects• Oversee site management of trials assigned to Project Management staff• Maintain confidentiality in all interactions with both internal and external entities • Supervise the Administrative Research Coordinators, Assistant Project Managers, and Project Managers to assure that all activities are completed appropriately• Participate in development and assumption on bids to external customers• Participate in development and finalization of protocol and ICF• Oversee protocol administration including pre-study work, initiation of sites, ongoing progress of trial and close out of sites• Oversee and ensure delivery of project deliverables• Provide leadership and direction to Project Management staff• Effective communication of protocol issues to all departments• Ensure proper escalation of site-related issues• Review and assist with development of SOPs and Study Plans• Ensure proper escalation of site-related issues according to procedures; assess root cause analysis • Ensure Management of Timelines and Metrics on trials• Review and oversee reconciliation of SAE database discrepancies• Assist with RFIs, RFPs, Blinded Feasibilities, Budgets• Assess subject safety and site/investigator adherence to FDA Regulations and ICH/GCP Guidelines• Ensure Serious Adverse Events are reported appropriately, accurately and in a timely manner• Developed processes for ongoing growth of the area within ACORN, and integrating those processes with other departments, sponsors and CROs

Greater Memphis Area

• Development, implementation, and management of investigator initiated trials• Oversee submission of proposal to funder• Receive letter of commitment from funder and initiate development of draft protocol• On final approval of draft protocol from funder prepare informed consent and release final documents to regulatory for site submission once site selections had been finalized• Determine site selections through feasibility questionnaire• Conduct pre-feasibility teleconferences with site staff and Principal Investigator• Ensure protocol administration including pre-study, site initiation, maintenance, follow-up and close out of trial• Implement actions to keep project on track- identify barriers• Provide training to all departments and retrain as needed• Ongoing site management including interim calls to site and troubleshooting • Effective communication of protocol issues to all departments • Prepare status reports and accrual graphs to management/funder as indicated• Oversee ongoing review of data• Facilitate final analysis, manuscript, and final study reports• Ensure Serious Adverse Events are reported appropriately, accurately and timely• Assess subject safety and site/Investigator adherence to FDA Regulations and ICH/GCP Guidelines

Greater Memphis Area

• Managed clinical operations for a multi-specialty research Site Management Organization• One of the founders of this organization• Responsible for development of approximately ten new research sites • Interviewed, hired, and trained all research staff at all research sites• Performed annual evaluations on all research staff; and responsible for promotion or termination of staff• Facilitated training of Principal Investigators at each site• Quarterly meetings with site administrators and physicians to assess research status at the site• Monitored status of subject accruals at each site• Met weekly with Medical Director to report status of sites• Worked with Director of Finance to establish site budgets• Met with pharmaceutical companies to market the sites within the organization• Worked with Manager of Medical Services to ensure quality and compliance of all sites with GCP Regulations• Met with Study Recruiter and Subject Recruiter to assess potential studies assigned to the sites• Developed processes according to growth of the Site Management Organization