Manager Clinical Research

Vignesh.Iyer

**** ****** ******, *** ***, Torrance, CA. 90503; 201-***-****; *******.****@******.*** www.linkedin.com/in/iyervignesh

Summary

Clinical Research Manager responsible for managing clinical operations process, monitoring adherence to SOP, GCP and FDA guidelines. Directly responsible for day to day performance of the clinical laboratory procedures and programs. Three plus years of supervisory experience with a strong background in managing clinical trial vendors (Industry sponsors, central labs, CRO’s) and in LC/MS/MS methodology for routine laboratory tests. Experience

Los Angeles Biomedical Research Institute

At UCLA-Harbor Medical Centre

Torrance, California

Clinical Research Manager July 2016- Present

Manage clinical laboratory focused on clinical trials and routine laboratory procedures adhering to CLIA, FDA and applicable regulatory procedures, guidelines and policies.

Assist in developing study protocols, CRF’s, laboratory manuals and other study related documents.

Interact with internal groups and external CRO’s, Vendors, clinical sites and industry sponsors to track study progress and project deadlines.

Manage and oversee laboratory protocols and procedures for timely completion of assays and study data submissions.

Development, maintenance and negotiation of budgets and vendor/clinical site payments.

Review study results and monitor quality control procedures in laboratory in accordance with FDA, CLIA and other regulatory guidelines.

Collaborate with R&D to develop test methodology for study specific compounds of interest especially using LC/MS/MS technology including method development and validation according to CLIA/FDA guidelines.

Develop and implement training workshops for laboratory technicians in techniques and procedures.

Assist investigators in organizing study data for grant progress reports, analysis for meeting presentations, and publications.

Organize and lead regular meetings with research personnel in the division.

Identify and resolve site issues

Maintain detailed knowledge of all assigned protocols, adhere to all protocol requirements to ensure the validity of the clinical research data, and transmit/distribute protocol information as needed. Select Laboratory Partners, Greensboro, NC

Toxicology Manager-LC/MS/MS Applications December, 2014 – June, 2016

Lead and supervise the toxicology department in performing sample analysis adhering to CLIA regulations.

Developing ultra-sensitive LC/MS/MS quantitative assays for pain medication and drug abuse for clinical samples including urine, blood, plasma and oral fluids.

Subject matter expert in development, characterization and implementation of appropriate extraction and purification techniques (Precipitation, Liquid-Liquid and solid phase SPE extractions.)

Perform method development, validation, analysis and proficiency testing for high complexity LC/MS/MS quantitative assays.

Monitoring day to day activities, evaluating workflows for lab technicians and troubleshooting experiments to run the lab in strict compliances with CLIA, FDA and SAMSHA regulations.

Analyzing and reporting drug concentrations to Clients from pain management and drug rehabilitation centers.

Technical support and troubleshooting in the use of the Shimadzu LC/MS/MS and GC-MS instruments as well as data analysis.

Train and instruct laboratory technicians, MT’s and MLT’s in techniques, instrument utilizations, methods and procedures.

Proactively interact with regulatory and compliance department to ensure the lab meets regulatory standards.

Document methodology and results, and provide concise conclusions about patient history to clients and physicians. SUNY at Buffalo

Graduate Research Assistant August 2012 – September 2014 Master’s Thesis: Oxysterol analysis by LC/MS and HPLC in Traumatic Brain Injury and Neurodegenerative Diseases.

Provided an insight into cholesterol and oxysterol levels at various stages of disease development and determined the extent to which oxysterol levels change with progressive decline in brain functions.

LC/MS analysis to determine oxysterol levels in mouse models of neurodegenerative disease and Traumatic Brain Injury. Data analysis and reduction on Shimadzu software platform

HPLC analysis of fat soluble vitamins, total cholesterol/ester profiling using SHIMADZU Prominence UFLC 20 series.

Prepared and analyzed plasma, cerebrospinal fluid and brain tissue samples for oxysterols using LC-MS.

Completed method validation for oxysterol analysis using LC-MS in accordance with FDA guidelines (ICH Q2 (R1)

Single staining and cell specific double staining for expression using CYP46 antibody against mouse and rabbit antibodies for neuronal and regional expression in thalamus and cortex.

qPCR for cyp46A1 mRNA, IHC, WB and IC for cyp46A1 proteins and neuronal markers. SUNY at Buffalo: Department of Biotechnology and Clinical Laboratory Sciences Teaching Assistant: Clinical Biochemistry, Bioseparation Techniques, Parasitology August 2012 – June 2014

Clinical Biochemistry (Theory): Proctoring students, set weekly assignments, grading assistance.

Taught Medical Technology undergraduates Bioseparation Techniques (Laboratory), Designed weekly experiments.

Maintained inventory and supply of reagents, submitted monthly reports, graded lab reports, and updated MSDS as needed.

Assisted lectures and laboratory coursework for Clinical Microbiology (Laboratory), Biochemical tests, Daily lab setup, Media preparation, Biohazard waste disposal

Clinical Parasitology and Urinalysis (laboratory) for undergraduates: Specimen collection and storage, setting up scopes and slides, set weekly assignments and quizzes. Education and Training

University at Buffalo, SUNY September, 2014

Master of Science – Biotechnology and Clinical Laboratory Sciences (3.5/4.0)

Vellore Institute of Technology, India

Master of Science – Biotechnology and Clinical Biochemistry (7.9/10.0) August, 2012 Bachelor of Science – Biotechnology (8.1/10.0) August, 2012 Workshops

MSACL 2018: LC-MSMS301: ‘Development and Validation of Quantitative LC-MS/MS Assays for Use in Clinical Diagnostics’, Russell Grant, PhD & Matthew Crawford,Level: 3 (Advanced).

MSACL 2017: LC-MSMS201: ‘Understanding and Optimization of LC-MS/MS to Develop Successful Methods for Identification and Quantitation in Complex Matrices’, Robert D. Voyksner, PhD, Level: 2 (Intermediate). Published Research

Narayanaswamy R., Iyer V., Soh K.T., Patel R., Smith I.C., Bodziak M.L., Ramanathan M., Browne R.W. (2013) A validated LC-MS method for oxysterol analysis in human plasma. Free Radical Biol and Med 65( Supplement 2): S53. http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0123771

Research poster "Annotation of Genes involved in Sec-SRP Secretion System in Kytococcus" http://digitalcommons.brockport.edu/cgi/viewcontent.cgi?article=1001&context=gradconf

Research poster “An LC-MS method for simultaneous determination of cholesterol, oxysterol and vitamin D levels in human plasma and cerebrospinal fluid.”

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