Marzia Islam
Clinical Research Associate @Montefiore Health System
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WORK HISTORY
Clinical Research Associate @Montefiore Health System
Collaborate with investigators and sponsors to plan and design clinical trials.2. Assist in the development of research protocols, informed consent forms, and study-related documents.3. Prepare and submit study protocols for regulatory and ethics committee approvals.44. Screen and identify eligible study participants according to protocol criteria.5. Obtain informed consent from participants and ensured they fully understood their participation rights and responsibilities.6. Maintain accurate and organized participant records.7. Create and maintain case report forms (CRFs) or electronic data capture (EDC) systems for data collection.8. Collect, record, and verify research data from participants in a timely and accurate manner.9. Monitor and manage data quality and integrity.10. Maintain a comprehensive understanding of regulatory requirements, Good Clinical Practice (GCP) guidelines, and ethical standards.11. Ensure all aspects of the trial comply with regulatory and institutional guidelines.12. Collaborate with clinical trial sites, investigators, and study team members.13. Manage the distribution and storage of study-related materials and investigational products.14. Safety Reporting and Adverse Events: Monitor and report adverse (AEs) and serious (SAEs) events to the appropriate authorities, sponsors, and investigators.15. Implement safety monitoring and reporting processes.16. Maintain accurate and complete trial documentation, including participant records, source documents, and study files.17. Prepare and archive essential study documents.
EDUCATION
York College of the City University of New York
Bachelor's degree, Pharmaceutical Sciences
ABOUT MARZIA ISLAM
Hi there! My name is Marzia Islam and I best define myself as a \'QA Scientist\' but also a…
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