Cassidy Woodworth

• Collaborated with cross-functional teams to coordinate the exchange of information, facilitating efficient trial execution
• Assisted in investigator study site selection and study start-up activities
• Created clinical project documents, including, but not limited to, study protocols, informed consent forms, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports
• Assisted in creation and maintenance of Electronic Data Capture (EDC) system
• Managed Trail Master File (TMF) documents to maintain readiness for audits and inspections
• Led communications with the research team and institutional review board
• Assisted with the preparation of IRB applications, including protocol and informed consents and obtained approval to conduct the study
• Implemented and monitored clinical trial to ensure sponsor/investigator obligations were met and were compliant with applicable local requirements and FDA and ICH guidelines
• Conducted monitoring visits to confirm protocol compliance, assess qualifications of study personnel, ensure “Good Clinical Practice”, and conducted close-out visits
• Initiated data query resolution and confirmed resolution in timely manner with study sites

In addition to below responsibilities-

• Oriented and trained new staff on proper procedures and policies
• Led and supported Research Intern team
• Recruited, determined eligibility, and scheduled initial screening appointments for research participants
• Managed updates and input for patient information database

• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols across multiple therapeutic areas, including diabetes, cardiovascular disease, weight-loss, migraines, vaccines, healthy volunteer, and device studies
• Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations
• Assisted in completion of source documents
• Collected and documented patient medical information, such as blood pressure and weight
• Completed EKGs and other tests based on patient presentation in office
• Updated inventory, expiration and vaccine logs to maintain current tracking documentation
• Answered telephone calls to offer office information, answer questions, and direct calls to staff
• Performed calibration and maintenance for study equipment, including YSI analyzer, DEXA machine, and EKG machine