Celeste Harrison, Phd Email & Phone Number

Sydney, Nsw, Au

- Developed high quality scientific, regulatory and clinical documents and presentationsprepared in compliance with regulatory requirements.- Prepared several clinical trial protocols and protocol amendments, Investigatorbrochures, patient information and consent forms, clinical study reports, SAE narratives,trial specific operational manuals, and manuscript preparation according to eachstatement of work, and had input into company specific medical writing style guides and best practices. - Reviewed and provided suggested edits to other members of the Medical Writing team.- Provided support to cross-functional teams to assist in the preparation of PK reports, trial registration applications (e.g., via ANZCTR), letters to HRECs, internal therapeutic area training materials, and executive summaries. - Prepared slide decks for training of site staff including the study Investigator at trialinitiation visits and information packages for Investigators, on request.- Regularly liaised with clients and external contractors, as required.- Developed several SOPs and work instructions, and assisted with internal document preparation for upcoming client audits.- Supported business development by providing input into budget and timelines forupcoming Medical Writing projects as well as developing slide decks to win business.

- Developed partnerships with Investigators/ KOLs/ healthcare professionals.- Supported sponsored and Investigator Initiated Trials by providing medical writingsupport for study design/ protocol development and preparation of documents forregulatory/ ethics submissions, communicating trial information to KOLs, conductingfeasibility assessments, and performing various medical writing activities (e.g.,preparation of Investigator Brochure, consent forms, clinical study reports, and otheressential trial documents, as required).- Provided input into content for medical educational programs/ foundations andassisted with the development of various therapeutic area training materials.- Presented internationally at educational sessions and attended global conferences.- Provided scientific support across all therapeutic areas to internal departmentsincluding clinical operations, data management, quality assurance and biostatistics, aswell as external parties, where applicable.- Implemented and managed research activities of partner laboratories andorganisations contracted for clinical studies.

Hunter Medical Research Institute

- Responsible for collation and communication (reporting) of laboratory results to the principal investigators at our trial sites.- Authored, reviewed, and approved several SOP’s and Technical Reports.- Responsible for the coordination of sample shipments and inventories, sample receipt andprocessing, and analytical testing of clinical trial samples for several phase 1 clinical trials.- Point of contact for the trial project managers, clinical research associates and other medical and scientific professionals to maintain the smooth running of ongoing clinical trials.- Undertook multiple scientific protocols including TCID50 and neutralisation assays, and molecular analysis by means of RNA extraction and RT-qPCR. - Conducted all work following GxP guidelines.- Resolved laboratory deviations and investigations, and implemented CAPA plans.

Newcastle, Australia

- Lecturer – human bioscience/pathophysiology for 3rd year nursing students. Topics rangedfrom circulation and respiration, embryology and reproduction, immunology, endocrinology, neurology, and psychology and involved the preparation of all teaching material (slide decks) for each class.- Facilitator for the problem-based learning tutorials undertaken by 1st and 2nd year medical students.

- Developed novel animal models of lung cancer to investigate how smoking contributes to disease development and drives its progression.- Developed abstracts/ poster presentations for Cancer Research Symposia.- Generated the first draft of, and had subsequent input into, a successful Cancer Council grant application which featured data solely generated from the project.- Created and optimised new laboratory protocols and safety/ ethics documents.

- Assisted and supervised groups of 2nd and 3rd year biomedical science students in their practical laboratory classes.- Disseminated important safety information and teaching material/ relevant journal articles.

- Worked on multiple research projects relating to respiratory diseases including COPD/ emphysema and asthma, as well as various lung malignancies.- Responsible for generating ethics applications, safety manuals/ policies (e.g., SOPs), and grant applications for submission to funding bodies such as the NHMRC and NSW Cancer Council.- Liaised with clinicians and other researchers regarding ongoing and upcoming projects and collaborations.- Taught/ assisted students and other researchers within the lab.

- Focused on the role of FLT3 (Fms Like Tyrosine Kinase 3) internal tandem duplications (ITD) within the juxtamembrane domain of the FLT3 receptor, and the inhibition of protein phosphatase 2A (PP2A) in FLT3/ITD+ leukaemia.

- Responsible for the genotyping for the mice used in mouse models to investigate cancer and kidney disease.

Doctor Of Philosophy (Immunology And Microbiology), Lung Cancer Research

Bachelor Of Biomedical Science (Hons), Leukaemia Research, First Class Honours

Bachelor Of Biomedical Science, Biochemistry And Molecular Biology