Description
SUMMARY An analytical and detail-oriented healthcare professional, with extensive experience in nursing, biotechnology, regulatory compliance, global safety, pre- and post-market studies, research and development, clinical trials and FDA compliance. Utilizes exceptional organization and communication skills to consistently set and meet high-quality standards. Possesses a proven ability to utilize a cross-functional skill set to guarantee proper patient care and analyze multiple clinical documents. Applies keen logic and attention to detail to resolve complex medical issues, delivering top-quality solutions that ensure the best quality of service in healthcare. KEY ACCOMPLISHMENTS * Successfully enrolled patients in appropriate clinical trial * Aggregate date from clinical trials reports and various databases for the distribution to Regulatory Affairs to be used for submission to the FDA or other regulatory bodies * Aggregate data from breast cancer registry for distribution to Executive Medical committee * Participated in the remediation process by auditing historical data to determine reportability * Participated in pilot program to determine process changes * Acted as safety senior nurse specialist in several studies for device sponsor. * Actively reviews files to capture adverse events to report to the FDA using the Medical Device Reporting system * Developed a process to transfer and integrate data from one data source to a single data repository. * Maintained breast cancer registry with accuracy and reported information to medical and regulatory affairs executives. * Reviewed study documents for pre - and post-market reporting of TAE and SAE to appropriate authorities. * Gathered data and managed line listings to ensure accuracy for multiple DBL in clinical trials. * Generated and approved MedWatch for submission to FDA. * Generated initial vigilance for appropriate regulatory agencies and competent authorities. * Possessed special sensitivity to meeting diverse needs in varied situations. * Demonstrated aptitude for developing new skills. * Developed rapport with patients, families, staff and other healthcare professionals. * Complaint investigation
Accomplishments
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