Krupen Patel Email and Phone Number

As a Research Coordinator and Trial Manager at CTU, I started working with multiple disease teams, after 2 years into my role, I was promoted to lead the Phase-II unit of CTU. I was responsible for managing various tasks along with personal trial management. • Designed matrixes to manage coordinator work efficiency, progress, and problem areas of concern.• Proposed and implemented scheduling guidelines through Allscripts EMR in order to make workflow more efficient and less error prone.• Worked closely with Budget and Contract team to establish better financial coverage for trials.• Helped in protocol, consent and regulatory document writing and review.• Worked with regulatory, finance, IRB teams, to streamline the study activation process, and reduced the 120 days activation to 60-90 days post PRMC approval.a. Successfully activated and put active patients on three trials within 45 days of PRMC approval, with the proposed guidelines.• Established training guidelines to counter the high turnover position and shortened the training period of Research specialist from 60 days, to 3 weeks.• Successfully managing GU Medical oncology team with 24 active patients, and 10 active clinical trials protocols.a. Also covered idle Melanoma team with startup studies and screening.• Being the liaison between clinical team and the sponsors to make sure all data points, and treatment plan is implemented.• Worked with IT and bioinformatics team to better implement in-house software to screen for patients with particular genetic mutations.a. This helped in identifying tougher patient population with in UH system and increased accrual.• Helping in data management, using sponsor specific EDC system and eCRFs.• Protocol specific adherence of pharmaceutical guidelines.• Accessing various portals for data management, patient randomization, and protocol driven sponsor specific activities.

1. Managing the multiple site Clinical Study financially and adhering to FDA, GLP, HSP, and IRB regulation for Clinical Research Protocol (CCRC). 2. Excellent at data management and analysis for the clinical study using statistical software, CTMS, and Windows software.a. Remote Monitoring, data and compliance verification of Kenya site.3. Budgeting and financially managing the entire research study.4. Establishing database system in Excel and Access or user-friendly upkeep, organization, and distribution of field samples.5. Teaching and supervising students on the GLP and various assays performed in the laboratory.6. Optimizing multiplex protocol for detecting drug resistance in population treated for Malaria using MAGPiX.Techniques learned:,Financial Management of Cohort, Compliance under IRB and FDA Regulation, Creating Databases.

As a Research Assistant, the following were my accomplishments,1. Managing lab financially, and responsible for leading the sales negotiation for the lab.2. Successfully generating murine transgenic knockout strain using a Ten-on/off driver.3. Culturing and maintaining Toxoplasma Gondii both in-vivo and in-vitro.4. Establishing Western blot protocol for detecting HSP protein in CD40 KO cells infected with T. gondii.5. Performing lavage and perfusion of animals infected with T. Gondii to mimic its in-vitro response.Techniques learned: Cloning, Sterile culture technique, handling of mouse and human cell lines, Western blot, primer design and optimization, DNA & RNA isolation, cDNA synthesis, PCR & qPCR, cloning, flow cytometry, protein purification.

As a Research Assistant, I was involved in several projects listed below:1. Lead the sales negotiations for the lab.2. Establishing an animal model for Oropharyngeal Candidiasis (OPC) to identify host recognition mechanisms during host-pathogen interaction.3. Characterizing the role of toll-like receptors in recognition of Candida during oral infection.4. Identify the role of inflammasome in host defense against C. albicans. 5. Defining the role of anti microbial peptide, β-defensin during C. albicans oral infection 6. Generation of null mutants of Candida cell wall proteins and hyphal mutants to understand their role in morphogenesis, host recognition and immune activation.7. Maintain, breed and genotype mouse colony which contain 27 different strains and maintain databases for ongoing projects and automatically update the historical data.8. Generate double knockout mice essential for characterizing the role of TLR’s and inflammasome during Candida infection.9. Training and supervising undergraduate and high school students during their summer projects.10. Perform terminal necropsy on infected animals, harvesting infected organs for IHC or other read out experiments, bronchoalveolar lavages, intraperitoneal (IP) injections, IP lavages and Intravenous injections for setting up bone marrow chimeric experiments.Techniques learned: sterile culture technique, handling of mouse and human cell lines, maintain and culture fungal and bacterial strains, primer design and optimization, DNA & RNA isolation, cDNA synthesis, PCR & qPCR, cloning, flow cytometry, protein purification, Western blot, ELISA, Bioplex, immunohistochemistry, mouse colony maintenance and genotyping, mouse breeding, GLP, Organizational skills.

Details included in CV.

Details included in CV.