Richelle Randazzo

Sr Clinical Trial Therapy Specialist @Novartis

Chicago, IL, US

Experienced Senior Clinical Trial Therapy Specialist with a demonstrated history of working in the biotechnology industry within Clinical Operations and within the Clinical Science & Innovation Team. Currently supporting the therapy function for three multi-site trials globally in gene therapy for pediatric rare disease. Support protocol development, selection and implementation of functional outcome measures. Analyze and interpret data, identify trends, and present findings. Using strengths of organization, efficiency and being highly motivated and solution-oriented to excel at the fast-paced role within a ground-breaking clinical development program. Skilled in Occupational Therapy, including neonatal development, cardiac disorders, sensory processing disorders, neurological disorders and rehabilitation. Collaborative research professional with a Clinical Doctorate Degree in Occupational Therapy with a specialty in neonatal developmental and early intervention. Additional job functions include: Providing oversight for investigative site clinical evaluators and study coordinators. Collaboration with study team and consultants to plan and execute initial clinical evaluator training/qualification and biannual reliability activities. Evaluation of study videos to assist in determining sufficient documentation to support Developmental Milestone achievement; Participation in process improvement, Collaboration to develop departmental Standard Operating Procedures, guidance, templates, and forms to adhere to ICH-GCP and global regulations.