The Sr. Associate Manager, Clinical Research provides technical and administrative support for multiple studies and must ensure that all activities are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, CPMP etc.), and Good Clinical Practices (GCPs). Contracted through third party Adecco.• Assists with the development and management of study related documents including clinical protocols, case report forms, study manuals, operational plans, recruitment content, and other study materials.• Ensures readiness of study supplies, study tools, devices, and investigational products (IP) for use in clinical trials.• Tracks and reports progress of studies including site certifications, subject enrollment, data collection, documentation of adverse events, and real-time study data• Creates and maintains registry postings, such as clintrials.gov• Initiates contracts and provides operational oversight of vendors and other external third parties such as patient advocacy groups and CROs• Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for study related meetings• Maintains relationships and addresses questions regarding procedural issues from clinical sites and helps identify areas of improvement

Responsible for:• Product design and functionality• Ai Engine and Ai troubleshooting• Product launch and development• Marketing and Monetization

• Manage multiple Clinical Trials and provide strategic/tactical planning, organization, and oversight of clinical study activities such as clinical site start up, budgeting, monitoring, regulatory reporting, vendor management, clinical supply management, and site payments.• Company TMF SME, driving the launch of CTMS/TMF vaults by Veeva Systems.• Reviews, approves, and projects all Clinical invoicing and entire Clinical Budget in tens of millions of dollars.• Develop, maintain, and monitor project timelines and allocated resources throughout the life of the study and continuously analyze trial performance to plan.• Ensure cross-functional coordination of project timelines directly with teams from Product Development, Quality Assurance, Clinical Affairs, Operations, Regulatory Affairs and Marketing.• Perform risk management and contingency planning activities to ensure that all potential study risks, such as delays in study milestones and increased study.• Lead project team meetings to ensure on-time deliverables.• Participate in evaluation and selection of clinical study vendors including CRO, Data Management, IRT, Central labs, Imaging, etc.

• Assigned as CTMA to multiple ongoing studies for Biktarvy(HIV), Sovaldi(HCV), Sunlenca/Lenacapavir(HIV) and support for other Gilead products. • Studies assigned to included: GS-US-380-6375, GS-US-380-6270, GS-US-334-1113(Pediatric and Adult HCV), GS-US-985-6693 (Global HIV study), GS-US-200-6487, GS-US-528-6364 (Purpose 2 Qualitative), GS-US-528-6365 (Purpose 1 Qualitative), • Manages and triages all global compassionate use requests for every Gilead product and every therapeutic area, including HIV, Inflammation, and Oncology. Ensures essential access to drugs like Remdesivir(Veklury) and Magrolimab.• Department TMF SME and member of TMF Global Business Council which oversees all TMF activities globally.Clinical Operations is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with all applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of Gilead’s products.The CTMA-Late Phase position plays a vital role in successful implementation and support of important Gilead Sponsored non-interventional, Collaborative (CO) and Investigator-Sponsored Research (ISR) projects.

[Promotion] The Clinical Logistics Specialist is an in-house sponsor position who is responsible for enrollment of study participants, scheduling investigational product manufacturing, and all logistics coordination activities involved in the cell journey.Work supporting the following breakthrough studies:• ZUMA-1 (Yescarta)• ZUMA-2 (Tecartus)• ZUMA-7 (Second line Yescarta)• ZUMA-12 (First line High risk large B-cell lymphoma)• ZUMA-14 (Yescarta + Retuximab[CD20] )• KITE-222 (CLL-1 Target in advanced acute myeloid leukemia [AML] )• KITE-037 (Allogeneic Yescarta)Primary focus was as a member of the ZUMA-12 study team.American Society of Hematology reported results of ZUMA-12 Interim Analysis:https://ashpublications.org/blood/article/136/Supplement%201/49/470027/Interim-Analysis-of-ZUMA-12-A-Phase-2-Study-ofUtilized Agile development to manage and enhance the global clinical trials platform of Kite Clinical, planning sprints, writing stories, and performing UAT. Global lead of Collaborations program, where others partner with Kite in the quest for further understanding of our therapies. eTMF S.M.E. to Clinical Logistics and member of our global Audit team.

The Clinical Logistics Coordinator is a primarily in-house sponsor position (although some travel is required) who will be responsible for enrollment of study participants, scheduling investigational product manufacturing, and all logistics coordination activities involved in the cell journey. Primary lead on multiple ZUMA trials with work supporting breakthrough Zuma-1 trial.

The Chemical Procurement Specialist role, located at a customer's site(Amgen), is dedicated to ensuring chemical compliance, optimizing chemical inventory, and making the Researcher's chemical experience safe, efficient and more productive.Responsible for vetting and placing orders worth millions of dollars on behalf of Scientists.Key Responsibilities• Chemical Compliance tracking and enforcement• Develop / follow necessary business processes for Order fulfillment and procurement• Ensure adherence to Control Zone / fire code thresholds• Ensure communication to R&D• Review incoming material Safety Data Sheets and labels to properly classify the hazard(s) and effectively communicate product regulatory information across technical and non-technical audiences.• Track inventory to ensure material duplication is reduced, and inventories are kept to an appropriate minimum.• Ensure all materials and quantities’ received are compliant with federal, state and local laws and permit requirements.• Respond to day-to-day Researcher inquiries related to regulatory matters.• Utilize chemical procurement tool in compliance with sourcing requirements.• Troubleshoot invoices, purchase orders, and shipping issues.

Independently performs, verifies, and provides feedback on complex and varied services including, but not limited to media preparation, laboratory duties, and troubleshooting, for a client base that include Research and Development, Early Discovery, Pre-clinical development and Quality.Other Responsibilities: • Perform complex calculations based on Molarity, percent by volume, dilutions, ppm, and ppb• Prepare high quality specialized media, including buffers, microbial agar plates, mammalian cell culture media, and antibiotics• Participate in individual or group projects that can include, cost savings analysis, learning groups, writing job training methods, and leading team meetings• Perform specific tasks associated with media prep, including but not limited to pH titration, osmolality adjustment, sterile filtration techniques, and aliquots• Verification, calibration, and use of common and specialized lab equipment including, but not limited to magnetic mixer, hot plate, micropipettors, autoclave, balances, laminar flow and fume hoods, pH and conductivity meters, osmometers, Blood Gas Analyzers, vacuum filtration, peristaltic pumps, and Nitrogen gas lines.Working for Thermo Fisher Scientific Inc. under the subsidiary Unity Lab Services (U.L.S) at Amgen Headquarters in Thousand Oaks.

• Inaugural and currently only Biology tutor at the College which supports greater than 15,000 students. Tutoring Chemistry and Mathematics as well.• Also hired as a Supplemental Instructor, where I work with a Professor [Dr. Rena Petrello] guiding student learning, and hosting student workshops after her College Math class.

• Helped setup a seven week program where High School students at Rio Mesa in Oxnard, will learn to 3D print.• Training undergraduates, both in software and hardware, to 3D print, who in turn will train the High School students.• Providing support for teaching the AutoDesk Inventor program to students, so they can draw in 3 dimensions.• Students tasked with building efficient wind mills, and testing their electricity generating potential.• Hired under Project ACCESO grant, under their S.T.E.M Outreach wing.

Biology and Chemistry research performed at CSUCI under Dr. Erich Fleming and Dr. Ahmed Awad.• Paid Position: 5-10 hours of work per week. • Part Time Employee• Paid through California State Budget and GrantFunded by Project A.C.C.E.S.O(Achieving a Cooperative College Education through S.T.E.M Opportunities):http://www.csuci.edu/projectacceso/about.htmBiology Research includes:1. Strawberry Research• Researching an alternative control to Fungal Verticillum and Fusarium wilt in Strawberries, due to future loss of Methyl Bromide fumigation. The effects of Methyl Bromide and the EPA's strong regulation of it can be read about here:http://www.epa.gov/ozone/mbr/qa.html2. Clean Energy Alternatives through Bio Bricks• Research methods to create Bricks without the use of heat based on work already performed.• Method involved is known as "Microbiologically induced calcite precipitation", and it uses microbes to create the bricks rather than high heat, a strong answer to the problem of Climate change.3. Classification of nearby Algae sources around CSUCI and Point Mugu. • Creating pure isolates of Algae surveyed from our local environment and classifying those organisms.• Creating a Winogradsky column using microbes from Mugu and understanding the important ecological cycling and ecosystem that is created.Chemistry Research includes:1. Working with Uridine to create compounds necessary in the function of Anti-Sense Nucleic acid Therapy.(Read about Anti-sense therapy here: https://en.wikipedia.org/wiki/Antisense_therapy)• Running columns to isolate our compound.• Becoming accustomed to working with strong chemicals like THF(Tetrahydrofuran) and Dimethylchloride(Dichloromethane)• Setting up, managing, and working with a RotoVap to remove solvents from solutions.• Creating TLC's (Thin Liquid Chromatography) strips to characterize our molecule.• Working in Anhydrous conditions: Baked glassware, Nitrogen gas seals, rubber stoppers, etc

S.T.E.M(Science, Technology, Engineering, and Math) Outreach AssistantFunded by Project A.C.C.E.S.O(Achieving a Cooperative College Education through S.T.E.M Opportunities):http://www.csuci.edu/projectacceso/about.htmhttp://www.csuci.edu/projectacceso/outreach.htmOur different Projects:1. S.S.D.E.P(STEM Skills and Discipline Explorations Pathways) Program: Go to Elementary and Middle schools with minority populations in Oxnard, doing experiments with the kids, inspiring them into science, and inspiring them into going to College.2. Great Inventors Program: Going to High Schools and teaching engineering students how to use a 3-D Affinia printer along with Cubify Invent CAD software for designing their own creations. Then setting up two competitions using the tools they learned to compete with one another and apply thier 3D printing skills.3. Pathways to College Program: Bus in Elementary and middle school kids to CSUCI and do an experiment with them while teaching the Scientific method.• Paid Position: About 10 hours of work per week. • Weekly meetings every Friday morning followed by Friday Outreach events the same day.• Part Time Employee• Paid through California State Budget and GrantWork includes Teaching Students from Grades 4-8 about:• College and Majors• Careers that require STEM Majors• Scientific Method and Scientific Thinking• Experimentation and Observation• Relevance of STEM careers in today's world and in the Future• Importance of proper Journal maintenance• Importance of Biodiversity and the Environment• The relevance of subjects like Math and Biochemistry in our WorldAll of this done with the aid of:• Videos• Experiments which are then repeated by the students. Examples of experiments include pH water tests, Code Breaking using Math concepts, and bottled rockets using water and Alka seltzer. • Small groups of 3 Coordinators, like myself, each with 3-6 kids, allowing for a very personalized touch.

Research Mentor - Dr. Erich FlemingProject overview:"On Santa Rosa Island, microbial mat communities will be collected from freshwater and saltwater environments. We will determine the microbial composition of each community using microscopy. These mats are primarily composed of cyanobacteria which are the primary producers for this environment. The mats are hydrated at high tide but dry out during low tide. Part of this project will entail measuring the dispersal of the microbial mat throughout the intertidal zone. Dry mat samples will be brought back to CI for analysis and identification. Mat recovery from desiccation will be studied by monitoring metabolic activity under various environmental conditions (temperature, salinity, nutrient availability). "Research also includes mapping out the different Algae communities around CSUCI and also looking at possible mechanisms of travel for these photosynthetic Bacteria. Simply put, how do they travel such large distances and what is the mechanism allowing bacteria to disperse so far?~~~~~~~~~~Project A.C.C.E.S.O Summer ResearchAccesso= Achieving a Cooperative College Education through STEM Opportunities• Paid research• Three weeks from May 28 2013, to June 15, 2013. • 40 hours a week (8 hours a day)15 students chosen from CSUCI and 15 students from other nearby Colleges.If chosen the students are assigned a professor in their current field and initiate research in their given discipline. The selection process is highly competitive and includes a large applicant pool. CSUCI alone has 4,000 students, of which only 15 can take part in Summer Research.

Involved in two projects: The first is creating site directed mutants of a protein on the m-TOR pathway known as RHEB2(RHEBL1).Abstract:"Our project was to create site directed mutants of RHEB, specifically RHEB2 (aka RHEBL1), and to look at any possible changes as a result of these specific mutations. An example of a site we chose was at the twentieth Amino Acid position of RHEB2 which codes for a Threonine. This twentieth Amino Acid position is believed to be a phosphorylation site and as a result is probably highly critical in some way to the functions of RHEB2. Mutating this position through site directed mutagenesis to an Alanine would remove that function and could allow us to better understand the importance of the Threonine as well as RHEB2 as a whole. Other positions were also chosen to be mutated based on scientific literature that showed them as an important site for RHEB2 function."The second project includes research into another protein in the same pathway known as TCTP (Translationally controlled Tumor Protein)Abstract:"TCTP has been hypothesized to impact the mTOR pathway via its interaction with the small G-protein, Rheb. In this study a possible link between TCTP and mTOR signaling was investigated by gene silencing using RNA interference. The effects were monitored via analysis of S6 phosphorylation via immunoblotting and cell viability using MTT proliferation assays respectively. Cells were treated with three different TCTP siRNAs in a dose dependent manner. Silencing was confirmed by semi-quantitative RT-PCR."Conferences:http://sccur.whittier.edu/abstract/viewabstract/tctp-silencing-and-mtor-signaling.htmhttps://ncurdb.cur.org/ncur/search/display_ncur.aspx?id=73122http://www.csuperb.org/oars/abstract_view_inline.php?id=199&year=2013&PHPSESSID=c47acce92d75229c3380a63b19cce4bbConverted to Paid Position Jan 2013• 5-10 hours of work per week.• Under the Auspices of Project ACCESSOhttp://www.csuci.edu/projectacceso/about.htm

Project Accesso Summer ResearchAccesso= Achieving a Cooperative College Education through STEMOpportunities• Paid research• Three weeks from June 11 2012, to June 29, 2012. • 40 hours a week15 students chosen out of two schools, CSUCI and Oxnard College.If chosen the students are assigned a professor in their current field and initiate research in their given discipline.~~~~~~~~~~~~~~~~~~Principle Investigator - Dr. Nitika ParmarResearch includes making site-directed mutants of the TCTP(Translationally controlled Tumor Protein) protein, through custom primer design. This will be in an effort to understand the proteins role in Cancer and specifically in the notorious Insulin-mTOR pathway.We work with CHO and HEK cells attempting to see if a mutant TCTP will indeed affect cell viability and implicate it as a GEF of Rheb1 and Rheb2.~~~~~~Tasks include:• Growing and splitting HEK and CHO cells. • Using the standard tool kits of Biotechnitians: • Micropipettes • Laminar Flow Hoods • Falcon containes • Gloves, Gown, and other Safety Equipment • Plates, etc.• Also making Site Directed Mutants using QuikChange 2 kitshttp://www.genomics.agilent.com/CollectionSubpage.aspx?PageType=Product&SubPageType=ProductDetail&PageID=383

Biotech Quality Assurance and Sales and Marketing:Worked under: Quality& Regulatory Management and the Bio Science Alliance.Quality and Regulatory ManagementQA Tasks:• Analyze Armagen S.O.Ps for accuracy.• Review Certification programs of varying Validation types.Bio Science AllianceSales and Marketing Tasks:• Create a Marketing plan for The Biotech Forum(Bio Science Alliance)• Attend nearby Chamber of Commerce meetings as representative of organization.• Create short "Elevator Speech" to introduce self and give brief summary about goals and mission of the Bio Science Alliance.• Research nearby potential sponsors and speakers for the organization.• Connect with mentioned sponsors and speakers.• Research and connect with Life science start ups.• Provide a formal presentation about the Bio Science Alliance to the local Chamber of Commerce.• Creating monthly events with their Agenda's and organizing everyone to attend and know the time and date. • Keeping track of minutes at those meetings as well.• Compiling a list of local Biotech, CRO, Pharma, and other Life science companies in the Ventura County area.