Sherry Fada

• Oversaw compliance of assigned studies with regulatory agencies including the IRB, FDA, and other governing bodies. Ensure study maintenance and activities also adhere to the Cancer Center Research Standard Operating Procedure.
• Oversaw research participant visits throughout study, preparing paperwork, completing case report forms, and interacting with research staff (study physicians, co-investigators, and research nurses) on participant progress while coordinating activities and education of other research staff/technicians.
• Monitored and documented all adverse outcomes, ensuring compliance with IRB and FDA reporting requirements, and maintained adherence to federal, state, and local regulatory and institutional policies.
• Prepare regulatory documentation, binders, and maintain proper personnel for monitoring visits on multi-site trials.
• Provided support to pharmaceutical companies and multi-disciplinary personnel on research studies. Collected charts and information during site visits and audits.
• Assist in research related staff training; and assist in other assigned clinical and administrative appointed tasks (develop training, conduct weekly trainings, orient new employees, etc.)
• Assist with protocol, eCRF and budget development for new research studies
• Managed multiple projects simultaneously while maintaining strict deadlines and quality standards.
• Oversaw operational workflows within multiple myeloma treatment programs, ensuring adherence to clinical protocols.
• Mentored junior staff on best practices in patient care and program procedures.

• Lead coordinator for Phase I-III clinical trials, both industry sponsored and investigator initiated
• Oversees all study activity from budget negotiation to study closeout
• Collaborated with PI and multidisciplinary teams to oversee protocol-specific activities, ensuring adherence to research standards
• Ensured execution of research protocol and tracked activities against specified timelines to maintain study integrity
• Compose all regulatory documentation in accordance with sponsor's expectations, internal IRB SOP's, FDA regulations and ICH Good Clinical Practice Guidelines
• Support and drive department initiatives including reducing time to open a trial
• Participated in pilot programs to enhance departmental processes, contributing to reduction of research billing errors
• Achieves highest possible ratings on all internal and external QA audits
• Coordinated multi-disciplinary research projects in chronic hematological conditions.
• Developed and maintained study protocols and regulatory documents for clinical trials.

• Provided customer support to over 1,300 clients while managing multiple carriers
• Managed accounting function for agency, overseeing $3.5M in annual sales
• Led implementation of new business accounts, handling financial quoting, data submission for policies, and providing insights to customers on policy status, coverage, and billing
• Project management for existing client accounts inclusive of processing all change requests, invoices, payments, policy expirations, renewals, client networking and claim submissions
• Consulted on software implementations and conducted staff training
• Ensured proper compliance to be within the state of Ohio regulations for insurance coverage
• 13 years

actively pursuing