TINA TANK

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. Able to work independently as needed or remote to complete needed deadlines. Have worked with several databases: EtQ, Trackwise and Epic. Resourceful Specialist offering expertise in problem-solving, data analysis and customer service. Adept at quickly learning new technologies and processes for driving success. Proven track record of successfully managing multiple projects and developing innovative solutions.

• SOCRA- CCRP completed, 2014
• ACLS-May 2017
• ASQ Member 2021-present
• Quality and Compliance Certification 2021-present
• MDSAP Audit Approach ISO 13485
• Regulatory Knowledge/Familiarity
• ICH-GCP, CE Marking, MEDDEV 2.7.1, MEDRA Coding

• Developed and implemented remediation strategies to address identified compliance gaps and ensure adherence to regulatory requirements.
• Collaborated with internal teams to design and execute corrective action plans, aiming to close compliance gaps promptly and effectively.
• Conducted thorough assessments of compliance gaps, analyzing root causes and implementing preventive measures to mitigate future occurrences.
• Interfaced With regulatory authorities and participated in audits and inspections, providing necessary documentation, and demonstrating compliance remediation efforts.
• Facilitated training sessions and workshops to educate employees on compliance regulations, reinforcing awareness and promoting a culture of compliance throughout the organintion.
• Monitored and tracked progress Of compliance remediation activities, ensuring timely completion and documentation of corrective actions.
• Engaged with external consultants and experts to obtain guidance and expertise in addressing complex compliance issues.
• Collaborated with cross-functional teams to update policies, procedures, and systems to align with regulatory requirements and close compliance gaps. Maintained thorough documentation and records of compliance remediation activities, ensuring transparency and audit trail for regulatory purposes.
• Regularly communicated progress and updates on compliance remediation efforts to senior management and key stakeholders, fostering accountability and transparency
• Certified in MDR/Quality Auditing
• Successful submission to central and local IRB
• Prepared Regulatory binders and gathered essential documents for preparation for scheduled monitoring.
• Successfully enrolled patients in appropriate clinical trial
• Aggregate data 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 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 appropriate vigilance documentation to submit to global agencies.
• 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.
• Educating patients of anticipated risk, possible side effects to the study drug or other medications.
• Complaint investigation