Beth Brown Email and Phone Number

Independent contractor working with biopharma companies and CROs in roles including Sr. CRA, Lead CRA, and Clinical Operations Manager.• Unblinded Monitor - Phase 3, multicenter, international trial in adult and pediatric patients undergoing complex cardiac surgery.• Back-up Project Manager - Study start up activities (US sites) for a Phase 2 metastatic pancreatic cancer clinical trial. Reviewed/approved site-specific ICF templates, reviewed/approved regulatory documents for site activation/initial drug shipment, reviewed patient enrollment packets for PHI. Negotiated site budgets and clinical trial agreements.• Clinical Operations Specialist - Worked closely with the medical group and project managers on the clinical development of small-molecule anti-infective therapeutics. Provided hands-on support of an ongoing Phase 2 clinical trial in C. difficile infection (CDI) including the oversight of the clinical CRO and lab vendors, review of data listings, tracking study metrics, and updating Clinical Trials.gov. Wrote and presented the clinical operations summary for monthly progress reports and meetings (both internal/cross-functional and external).• Clinical Development Special Projects - Reviewed patient diary data and data listings for an ongoing Phase 3 clinical trial in calciphylaxis (CUA).• Unblinded Data Monitoring Committee (DMC) Coordinator - Phase 2 clinical trial in subjects hospitalized with COVID-19. Scheduled DMC meetings, maintained both a blinded portal and an unblinded portal with respective data, took minutes, and oversaw the completion of action items.• Lead CRA - Large Phase 1 SAD/MAD study in healthy volunteers and participants with Becker Muscular Dystrophy (BMD). Conducted the site initiation visit (SIV), interim monitoring visits (IMVs), and close out visit (COV) at Phase 1 Unit. Performed interim monitoring visits using a hybrid model of on-site and remote monitoring visits. Participated in study related meetings and teleconferences.