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About: A pharmaceutical formulation scientist / CRA I am a highly motivated Clinical Research Associate with over 4 years of experience with a deep passion for the clinical research industry. I am a focused, dynamic, and strong team player with in-depth understanding of protocol processes, proper documentation based on ALCOA-C principle, ICH-GCP guidelines, and proper reporting of ground zero, SAEs, and SUSAR. Exceptional in aspects of management, execution, organizing, setting up, and implementing a system for getting a task completed. Great multitasker with excellent interpersonal communication with the PIs, SCs, and other site staff. Comprehensive understanding of the Serious Adverse Event (SAE) reporting, processing, and following up on these. Proven track record of monitoring excellence evidenced by Sponsor (client) co-monitoring and sponsor audit. Vast experience in pharmaceutical formulation in developing innovative and efficient drug formulations that meet high-quality standards. I have developed and improved my wealth of skills in developing and characterizing novel drug delivery systems. I am efficient in the use of various laboratory equipment following SOPs, GLP and GMP. I am highly optimistic with a passion to contribute and excel in any challenging environment or position I find myself in I have a strong interest and great passion for drug development, clinical trials and a dedicated advocate of subjects’ safety, data integrity and compliance to study protocol and regulatory requirements
Job: Monitor