Jennifer Crawford-Thompson

Emerging Brands Oncology Project lead in the US that was responsible for delivering AZ's policy and position paper on using human samples for research, AZ's Clinical Development SOP on Management of Human Biological Samples Acting as the project lead in the US. Train and mentor members of Clinical Development and Discovery on the overview and awareness of the life cycle management of human biological samples and the BIOSES Project. Coordinate global (Sweden, UK, US) exchange of information on the Global Laboratory Management Network. Coordinate operational aspects of clinical studies to agreed time, cost and quality and continue to ensure all legal and compliance requirements are met Maintain permanent contact with external key stakeholders and external service providers and ensure that all deliverables are met according to study specifications. Lead the preparation of country specific agreements and review all of the required key documents, contracts and budget negotiations. Author key sections of several Clinical Protocols, Protocol Amendments, and Informed Consents and facilitate the exchange of information in order to produce a compliant document with country specific regulatory requirements. Create and Update specific Drug Safety Plans and ensure 100% compliance. Specifically created unique safety plans for the National Cancer Institute (NCI) Collaborations. Establish and facilitate interactions with key stakeholders such as MCs, CROs, study sites, and third party vendors to identify and resolve operational and feasibility issues. Create training materials for Investigator and Monitors meetings. Support the study delivery team and Clinical Quality Management in the development of and implementation of audits and regulatory inspections Regulatory Preceptorship 2009

Site Manager on JUPITER trial (Crestor). Provided direct site contact between regional monitors and investigator sites while monitoring study conduct and progress and identifying and resolving issues with potential impact on tracking, quality, timelines and budget Implemented Study Delivery and Clinical Development strategies Created and implemented a Subject Retention Program to ensure the study met the needed number of evaluable patients. Communicated and ensured integration of information between the Clinical Trial Management Systems and other related systems Proactively identified study related issues and provided recommendations for resolution Provided data analysis of study databases and compiled patient data and graphical analysis of subjects in order to inform key stakeholders of study progress

Coordinated and organized the delivery and scientific analysis of clinical study trials looking at Inflammatory Bowel Disease (IBD), following FDA GCP guidelines. Performed the screening and randomization, patient recruitment, site visits, generation and clinical analysis of familial registry, and collected Institutional Review Board requirements regarding protection of human research participants. Acted as Laboratory Manager & Supervisor, maintaining and managing all budget related aspects Performed Epstein-Barr transformation and Signal Transduction Pathway analysis of all patient B lymphocytes Performed molecular, cellular, and genetic analysis to define pathways that are directly involved in the etiology of IBD and to help identify a targeted patient population as it applies to personalized medicine (Including DNA Analysis; frequency analysis, protein extraction, western blotting,, gene microarrays, gel shift assays, flow cytometry, ELISA, gene synthesis & recombinant cloning techniques)

Department of Neuroscience & Anatomy Investigated growth factor function, regulation, and control of proliferation of epithelia of the developing brain and mammary gland. Established a specific gene-targeted mutant mouse line. Performed molecular and cellular analysis, Steroid Assays, Relative Quantitative Gene Specific, radioactive southern blotting and polymerase chain reaction (PCR) to identify specific genotypes, radioactive in situ hybridization, immunocytochemistry Managed laboratory operations including overseeing graduate students, medical students, & personnel from collaborating laboratories

Summa Cum laude, graduated top of my class. Dean's Award for Academic Excecellence