Sara Mathews's Email

Clinical Scientist with experience in many aspects of global clinical trial design, development, and management. Experienced in protocol and protocol amendment writing, consent form development and review, study start-up procedures and regulatory requirements for submission. Additionally specializing in safety review and data line listing review, CRO and vendor management, investigational product labeling and tracking, and timeline/budget development. Also a biomedical researcher with broad experience with many laboratory protocols in biology and chemistry with focus on the extraction and analysis of DNA and RNA. Strong familiarity with DNA/RNA analysis and quality management using electrophoresis, western blotting, and quantitative PCR, human cell line growth and experimentation, and small mammal surgical procedures (mice).

Clinical Scientist and Operations Lead @ - Overseeing the clinical operations team in the management of global registration-enabling clinical trials - Leading program-wide safety management team for assessment of program-level safety data and trends. Also involved in development and finalization of safety reporting documents, including Investigator's Brochures and DSURs - Contributing to the development of Briefing Packages for End of Phase 2 Meetings and other face to face meetings with the FDA and EMA regulatory authorities - Contributing to the development of annual plans and forecasting - Leading investigator outreach and discussions - Conducting site initiation visits - Clinical Study Report writing and review - Overseeing internal responsibilities on Investigator Sponsor Trials From September 2015 to Present (4 months) Senior Clinical Trial Manager @ Managing multiple Phase 1 and Phase 2 international oncology trials in solid tumors and lung cancer - Managing study budget and overall program timelines - Overseeing the submission of documents to Regulatory Authorities and Ethics Committees/IRBs in Europe and North America - Tracking, projecting, managing drug inventory and shipments, overseeing expiry update processes - Reviewing patient eligibility - Writing/reviewing protocols and protocol amendments - Writing Investigator Brochures - Writing Development Safety Update Reports - Managing multiple vendors and working with CROs (INC, Quintiles) - Reviewing sample and data reconciliation - Data Listing Review to ensure correct entry of data into the electronic data capture system (RAVE) - Drafting and reviewing Clinical Study Reports (CSR) - Conducting site initiation visits - Leading dose escalation calls - Identification of and negotiation of contracts with study vendors/functional service providers - Site selection and presentation of study to Investigators - Developing study manuals and reference documents - Writing master informed consent (ICF) templates and reviewing site-specific ICFs From May 2015 to Present (8 months) Clinical Trial Manager @ Managing multiple Phase 1 and Phase 2 international oncology trials in solid tumors and lung cancer - Overseeing the submission of documents to Regulatory Authorities and Ethics Committees/IRBs in Europe and North America - Tracking, projecting, managing drug inventory and shipments, overseeing expiry update processes - Reviewing patient eligibility - Writing/reviewing protocols and protocol amendments - Writing Investigator Brochures - Writing Development Safety Update Reports - Managing multiple vendors and working with CROs (INC, Quintiles) - Reviewing sample and data reconciliation - Data Listing Review to ensure correct entry of data into the electronic data capture system (RAVE) - Drafting and reviewing Clinical Study Reports (CSR) - Conducting site initiation visits - Leading dose escalation calls - Site selection and presentation of study to Investigators - Developing study manuals and reference documents - Writing master informed consent (ICF) templates and reviewing site-specific ICFs From January 2013 to Present (3 years) Clinical Trial Associate @ Assisting in the coordination of multiple Phase 1 and Phase 2 international oncology trials in solid tumor cancers, breast cancers, and ovarian cancers. - Managing the collection of SAE reports - Reviewing and approving informed consent forms - Reviewing and approving monitoring visit reports - Assisting in the submission of documents to Regulatory Authorities and Ethics Committees in Europe and North America - Data Listing Review for the correct entry of data into the electronic data capture system From January 2012 to December 2012 (1 year) Clinical Trial Associate @ Working on a phase III clinical trial of OncoVEX, an oncology vaccine designed to treat late-stage melanoma. My main responsibility is working with the independent assessment committee, the Endpoint Assessment Committee (EAC), to ensure that patient response to treatment is genuine. This responsibility includes: 1. Tracking patients ready for review, and verifiying complete and clean data and imagine uploads, and monitoring the submission packages for the EAC 2. Assisting in the transition from small company processes to the high expectations of big pharmaceutical companies like Amgen, accomplished through acting as a BioVex representative in meetings, both face to face and via telephone. 3. Providing support to site monitors and coordinators to correctly and thoroughly enter and verify patient information and data 4. Maintaining drafts and final versions of charters and manuals for EAC members and WorldCare Clinical LLC, our imaging company 5. Participating in audits of selected vendors (e.g. WorldCare Clinical, LLC) 6. Providing support to site monitors and coordinators regarding protocol adherence and deviations 7. Data Listing Review to identify incorrectly entered data in the online electronic data capture system 8. Presenting at investigator meeting From February 2011 to December 2011 (11 months) Clinical Research Coordinator @ Coordinating a clinical research study assessing the effectiveness of the nicotine vaccine NicVAX™ (Nabi Pharmaceuticals) as a method to cease cigarette use 1. Enrolling, scheduling and following volunteer research subjects. 2. Protocol adjustment administration in accordance to IRB review and acceptance 3. Budget and contract negotiation and upkeep 4. 1572, financial disclosure and electronic case report files (eCRF) execution 5. Performing behavioral counseling for subjects to help them prepare a plan to quit smoking and to maintain their quit 6. Informed Consent Form composition 7. New protocol administration for review board approval 8. Assisting the registered nurse in office visits for screenings, injections, and counseling appointments 9. Updating study and department databases for subject organization 10. Ordering and receiving supplies, including proper care of vaccination supply 11. Conducting simple urine drug and pregnancy tests; centrifugation and pipetting of blood serums From January 2010 to February 2011 (1 year 2 months) Research Associate @ investigating the genetic effect of maternally ingested cigarette smoke exposure on the lung development of fetal mice 1. Removal of lung, liver, and spleen tissue from mice and use of human tissue samples and cell lines for RNA and DNA analysis 2. DNase and reverse-transcriptase reactions for preparation of RNA for analysis 3. Analysis of quality, size, and type of RNA and DNA using gel electrophoresis and PCR 4. Analysis of messenger-RNA using Real-Time PCR and a variety of primers; instruction of the RT-PCR machine to co-workers 5. Analysis of quality, size and quantity of protein using Western Blotting. 6. Growth, care and transfection of human cell lines (e.g. A549 cells) 7. Treating the mice with cigarette smoke, and scheduling/supervising team of people also responsible for the proper treatment of mice 8. Preparation and dilution of buffers and chemical solutions 9. Entry and organization of data using Microsoft Excel, Word, and Powerpoint 10. Ordering and receiving supplies, scheduling use of machines From June 2007 to December 2009 (2 years 7 months)

Bachelor's of Science, Neurobiology @ Colby College From 2003 to 2007 1 course, Organic Chemistry @ Harvard University From 2010 to 2010 Sara Mathews is skilled in: Western Blotting, qPCR, Biotechnology, Clinical Trials, Lifesciences, Oncology, Clinical Research, Cell Culture, Molecular Biology, PCR, ELISA, Cancer