Christina S. Email & Phone Number

Miami, Fl, Us

Miami, Fl, Us

Horsham, Westsussex, Gb

• Verify clinical trial data by performing Source Data Verification and ensure accurate and complete documentation in the Trial Master File. • Provide training and support to study site personnel on protocol requirements, data collection methods, and regulatory compliance, fostering strong relationships with investigative site staff.• Manage remote and onsite visits to clinical trial sites, ensuring adherence to protocol, regulatory requirements, and Good Clinical Practice guidelines.

• Contribute to the development of clinical trial protocols, informed consent forms, and standardoperating procedures, ensuring precision and adherence to regulatory guidelines.• Strategize, develop, and manage program efforts in accordance with organizational goals.• Assist in the preparation of 510K application, contributing to the regulatory process.• Develop and design pitch decks showcasing key project objectives, strategies, and outcomes to stakeholders

Raleigh, North Carolina, Us

• Led the development and implementation of safety management plans for post-marketing,guaranteeing comprehensive monitoring and assessment of drug safety.• Managed global safety databases, overseeing the collection, processing, and analysis of adverseevent reports from diverse geographic regions.• Collaborated with cross-functional teams worldwide to integrate safety measures seamlessly into the trial's strategy.• Ensured meticulous adherence to regulatory requirements, prepared and submitted safety reports to health authorities globally (FDA, European Medicines Agency, Australian Government: Therapeutic Goods Administration etc).

Vancouver, Washington, Us

Emergency department• Assisted in the initial assessment and prioritization of patients based on the severity of their conditions.• Provided support during medical procedures and interventions carried out in the emergency setting.• Highly skilled in immediate response and administration of CPR during cardiac emergencies.Neurology• Assisted patients with mobility issues due to neurological conditions.• Monitored and documented patients with neurological conditions, including seizure activity.• Assisted in educating patients and their families about neurological disorders and treatment plans.Cardiology• Monitored cardiac rhythms and assisted in the care of patients with heart-related conditions.• Provided support during cardiac catheterization procedures.• Supported the performance and documentation of ECG procedures.Radiology• Assisted in preparing patients for various radiological procedures, explaining the process, and ensuring their comfort.• Ensured safety protocols were followed during radiological examinations.• Provided support during imaging procedures such as X-rays, CT scans, or MRIs.