Clinical Research coordinator with three years of experience in project management, clinical trial operations, quality control and compliance, and coordination of inter-institutional research collaborations with Regulatory Affairs Certification (Pharmaceutical) from RAPS. Excellent organizational and communication skills and an active member of the professional scientific community.
2016 Present: Regulatory Affairs Professional Society 2008 Present: Recessive PKD Core Center, Univ.
of Alabama, Birmingham, AL 2013 Present: Extended faculty; Mayo Translational Polycystic Kidney Disease Center 2003 Present: American Society for Cell Biology 2003 2013: American Society of Nephrology 1995 1997: Cystic Fibrosis Foundation SELECTED PRESENTATIONS AND PARTICIPATION IN WORKSHOPS Risk-Based Monitoring: Transforming Theory into Practice, | COVANCE WEBINAR, March 2016 Microsymposium presenter, Abnormal Expression of Laminin-332 Promotes Cell Proliferation and Cyst Growth in Autosomal Recessive Polycystic Kidney Disease | ASCB annual meeting, December 2015 Session Chair, Research Integrity and the Responsible Conduct of Research | The Eighth International Conference On Ethics in Biology, Engineering & Medicine, St.
Francis College, April 2015 Invited Speaker, Investigation of the role of aberrant laminin assembly in PKD cystogenesis | Mayo Translational PKD Center Retreat, Mayo Clinic, May 2012 Invited Participant, Genzyme Investigators meeting, Denver, CO, Nov 2010 Invited Speaker, Jim Hensin, A New Puppeteer In Epithelial Morphogenesis | Department of Biology, Brookhaven National Laboratory, February 2010 Invited Speaker, GSK-3/mTOR signaling regulates extracellular matrix deposition of hensin, a key regulator of kidney adaptation to metabolic acidosis by blocking galectin-3 secretion | American Society of Nephrology Renal Week, October 2009 Invited Speaker, Molecular mechanisms of epithelial differentiation regulated by hensin, the rabbit homologue of innate immunity defense protein gp340/DMBT1|University of Southern Denmark, June 2007 Invited Speaker, Cyclosporin Causes Distal Renal Tubular Acidosis by Preventing Hensin Polymerization | American Society of Nephrology Renal Week, September 2003 BOOK CHAPTER | Extracellular Matrix Abnormalities in Polycystic Kidney Disease In: Novel Insights on Chronic Kidney Disease, Acute Kidney Injury and Polycystic Kidney Disease, (Editor: S.
Vijayakumar) Intech Publishing, Croatia ISBN 978-953-51-0234-2 | www.intechopen.com/books/novel- insights-on-chronic-kidney-disease-acute-kidney-injury-and-polycystic-kidney-disease.
SUNY CobleskillAsst. /Associate Professor
Incorporated active-learning strategies into lecture and lab courses on General Biology, Cell Biology, and Biochemistry at Cobleskill and at the Jinling Institute of Technology Reviewed STEM grants for National Science Foundation.
Chaired a session on Research Integrity and the Responsible Conduct of Research and participated in critical thinking assessment (CAT) workshop.
University of Rochester Departments of Pediatrics and Pharmacology & PhysiologyRochester, NYResearch Assistant Professor and Assistant Professor
Brought an Otsuka-sponsored clinical study on polycystic kidney disease (PKD) managed by a CRO (Covance) to the University of Rochester and served as its sub-investigator.
Identified potential study subjects by analyzing EHRs for inclusion exclusion criteria.
Using effective networking and communication skills, enrolled most of the eligible patients after obtaining informed consent within the targeted period.
Interacted with the sponsor, PI, CRO and the IRB to modify the study protocol and obtained regulatory approvals for the study within few weeks.
Proactively coordinated baseline and follow-up study visits and managed all aspects of the study including administering questionnaires, processing lab samples and analyzing data.
Minimized data backlog issues by proactively monitoring the data management process including preparing CRFs, managing the EDC system, and by receiving and shipping lab supplies and samples on time.
Ensured data integrity and validity and provided regular feedback to the CRO and sponsor on project deliverables.
Coordinated the clinical trial team that included internal and external study personnel, hosted study-related meetings and prepared study reports.
Negotiated and managed the study budget and trained in HIPAA, Electronic Data Capture system (EDC), eRecords (EHR) and Blood-borne pathogen handling.
Established cross-functional teams consisting of scientists from Stanford University and Mayo Clinic and identified laminin-332 as a novel biologic for the treatment of PKD.
Presented Research findings in American Society of Nephrology annual meetings, FASEB PKD conference and in Mayo Clinic PKD center; a manuscript is pending publication.
Hired and managed a team of staff and mentored several undergraduate students.
Columbia UniversityNew York, NYPost-doctoral fellow and Associate Research Scientist
As a senior scientist, managed the day-to-day activities of the laboratory, including ordering lab supplies, developing SOPs for key experiments, ensuring compliance with chemical, biological, radiation and fire safety regulations.
Working with the PI and other lab members, discovered the role of hensin in the differentiation of kidney, prostate and intestinal epithelial cells.
Collaborated with other researchers in elucidating the role of hensin in prostate-cancer, alachlor-induced oncogenesis and in metabolic acidosis of the kidney Served as a consultant for a Biowhittaker project to develop novel matrix components that could promote prostate epithelial differentiation Conducted experiments, analyzed data, organized results in tables, graphs and figures, wrote the manuscript and published them in high-impact peer-reviewed publications.
Presented research findings in national and international meetings.
Rensselaer Polytechnic InstituteTroy, NYDoctor of Philosophy: BiologyBiology Structural Investigations on Cytochrome P450scc
Advisor: John C. Salerno, Ph.D
SELECTED PEER-REVIEWED PUBLICATIONS (OUT OF 26 TOTAL) 1. Paragas N, Kulkarni R, Werth M, Schmidt-Ott KM, Forster C, Deng R, Zhang Q, Singer E, Klose AD, Shen TH, Francis KP, Ray S, Vijayakumar S, Seward S, Bovino ME, Xu K, Takabe Y, Amaral FE, Mohan S, Wax R, Corbin K, Sanna-Cherchi S, Mori K, Johnson L, Nickolas T, D'Agati V, Lin CS, Qiu A, Al-Awqati Q, Ratner AJ, Barasch J (2014). -Intercalated cells defend the urinary system from bacterial infection. J Clin Invest. 124:2963-76. 2. S. Vijayakumar, Dang S, Marinkovich MP, Lazarova Z, Yoder B, Torres V and Wallace D. (2014) Aberrant Expression of Laminin-332 in ARPKD Contributes to Cystogenesis by Altering Principal Cell Proliferation. Am J Physiol Renal Physiol. 306:F640-54. 3. S. Vijayakumar, Peng H and Schwartz GJ. (2013) Galectin-3 Mediates Oligomerization of Secreted Hensin Using its Carbohydrate Recognition Domain. Am. J. Physiol. 305:F90-99 4. S. Vijayakumar, H.Erdjument-Bromage, P.Tempst and Q. Al-Awqati. (2008) Role of Integrins in Hensin Assembly and Function in Cultured Intercalated Cells. J. Am. Soc. Neph. 19: 10791091 5.G.J. Schwartz, S. Tsuroko, S. Vijayakumar, S. Petrovic, A. Milan and Q. Al-Awqati. (2002) Acid incubation reverses the polarity of intercalated cell transporters: An effect mediated by hensin. J. Clin. Inves. 102, 89-99. 6. S. Vijayakumar, J. Takito, C. Hikita and Q. Al-Awqati. (1999) Hensin remodels the apical cytoskeleton and induces columnarization of intercalated epithelial cells: processes that resemble terminal differentiation. J. Cell. Biol. 144. 7.W.C. Wigley, S. Vijayakumar, J.D. Jones, C. Slaughter and P. J. Thomas. (1998) Transmembrane domain of Cystic fibrosis transmembrane conductance regulator: Design, characterization and secondary structure of synthetic peptides m1-m6. Biochemistry. 37, 844-853.