Paul Ian Cross

Director @PIC Enterprises Limited

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PAUL IAN CROSS, BSc (Hons), MSc, PhD, is a scientist, writer, author and creative entrepreneur. Paul has a Bachelor’s degree in Applied Biology, a Master’s degree in Clinical Research and his PhD project investigated the benefit-risk assessment of medicines from the patients’ perspective. With over twenty years’ experience in clinical research, Paul has been involved in the design, set-up or delivery of over a hundred clinical studies, including first-in-human clinical trials in gene and cell therapy and COVID-19 vaccine research. Paul provides consultancy services to organisations who oversee or manage clinical research, including clinical trial set-up, ICH Good Clinical Practice oversight and project management, science communication, science writing and research training. He is an expert in clinical trial ethics and regulation and has been a keynote speaker at several clinical research conferences. He is regularly contracted to undertake investigations and audits of clinical trial investigators and their sites, identifying non-compliances and reporting on research misconduct. Paul provides research training in quality management and pharmacovigilance and is also guest lecturer at several UK universities, teaching doctoral students about research principles. His engagement with science extends far beyond his professional research. With a keen focus on education, Paul strives to make STEM subjects—Science, Technology, Engineering, and Mathematics—accessible and interesting for both children and adults. This educational drive is evident in the compelling STEM content he shares across his social media platforms. With a solid foundation in biology and a keen interest in health, medicine and nature, Paul’s scientific curiosity also spans technology, environmental sustainability, climate change and space exploration. His fascination with artificial intelligence and the possibility of alien life often finds their way into his science fiction narratives, adding a layer of intrigue to his stories. Ultimately, Pa

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Work Background

PIC Enterprises LimitedDirector

Sep. 2017London, UK · RemoteClinical research consultancy, research training, writing of STEM-inspired books for children and young adults. Freelance Writer for Medical News Today.

NIHR (National Institute for Health Research)Research Educator, GCP Subject Matter Expert & Learning Advisor

May. 2019 - Nov. 2022London, United KingdomeLearning & face to face research course development & content creation (written, video, audio, animation) in collaboration with the NIHR's Digital Learning Designers, to ensure courses and resources are both engaging and impactful. Guest editor for the NIHR Learn Insights CPD training resource. From 2019-2022, I led on updating the suite of online GCP courses to ensure they were representative of all colleagues, all patients and the public from both an equality, diversity and inclusion and an accessibility perspective.

Guy's and St Thomas' NHS Foundation TrustR&D / BRC Quality Assurance Manager

Dec. 2010 - Aug. 2017Research and Development / Biomedical Research CentreManagement of the GCP quality management system across the Guy's and St Thomas' Clinical Research Facilities including policy development and the writing of Standard Operating Procedures Risk management for early phase clinical trials Line management for the CRF Quality Team; consisting of a CRF Data Analyst and two CRF Quality Assurance Associates Quality Lead for all external audits and inspections conducted by the MHRA, EMA and FDA. Project Manager for the Trust’s Phase I Accreditation Project, working towards gaining accreditation to conduct First in Human Studies under the MHRA’s Phase I accreditation scheme. Biological Safety Officer for all advanced therapy (gene and cell therapy) trials conducted in the Clinical Research Facilities Chair of the NIHR UKCRF Quality Assurance Workstream