Jerry Kelvin

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I am a Principal Investigator and Clinical Trial Pharmacist of Record with over 15 years of progressive experience leading and supporting clinical trials across industry-sponsored, investigator-initiated and global clinical trial networks. My work is grounded in scientific rigor, regulatory excellence and a strong commitment to improving participant outcomes through high-quality trial implementation. As a Principal Investigator, I provide strategic leadership, oversee ethical and regulatory submissions and ensure compliance with national and international regulatory requirements. I am actively involved in clinical research implementation work, budgetary oversight and multi-stakeholder collaboration, working closely with sponsors, CROs, regulatory authorities and site teams to deliver trials effectively and to the highest scientific and ethical standards. My professional foundation as a Clinical Trial Pharmacist has equipped me with deep, hands-on expertise in the end-to-end management of investigational products, from importation, storage and accountability through dispensing to participant use, in strict adherence to Good Dispensing Practice and Good Clinical Practice. I have experience in managing participant randomization, maintaining treatment group integrity and upholding blinding and un-blinding procedures in accordance with protocol requirements. I have led the development and implementation of Standard Operating Procedures (SOPs) and study-specific pharmacy procedures, ensuring operational alignment with GCP, sponsor expectations and regulatory guidelines. My responsibilities included oversight of cold chain management, maintenance of investigational product storage conditions, and procurement of pharmacy supplies and delivery of protocol-specific training to pharmacy and study staff. I have coordinated and prepared pharmacy monitoring, audit and inspection visits, ensuring compliance with local and international research pharmacy standards and consistent application of ALCOA-C principles in all pharmacy documentation and practices. I am meticulous, detail-oriented and committed to seeing tasks through to completion while maintaining accuracy and accountability. I bring a proactive and self-directed approach to my work, with strong organizational, interpersonal and communication skills that allow me to manage competing priorities effectively. Through this combined leadership as a Principal Investigator and operational expertise as a Clinical Trial Pharmacist, I strive to strengthen research systems, enhance trial outcomes, contribute to the development of innovative therapies and support evidence generation that informs clinical practice and healthcare policy.