Clinical Research Engineer

VARUNA ASTHA

+1-813-***-****, Tampa, FL, USA

***********@*****.***, https://www.linkedin.com/in/varunaastha/

QUALIFICATION

Master of Public Health (MPH) in Biostatistics Expected Dec 2019

University of South Florida (USF), Tampa, FL, U.S.A

Master of Technology (M. Tech.) in Health, Safety, & Environment 2011-2013

University of Petroleum & Energy Studies (UPES), Dehradun, India

Bachelor of Technology (B. Tech) in Computer Science & Engi

neering 2007-2011

Dr. A.P.J. Abdul Kalam Technical University (AKTU), Lucknow, India

EXPERIENCE

Graduate Student, MPH Biostatistics Aug 2017-Present

Department of Epidemiology & Biostatistics, College of Public Health, USF, Tampa

Conducted research study to analyze the association between smoking and prevalence of COPD, Emphysema, or Chronic Bronchitis in the participants of Behavioral Risk Factor Surveillance System (BRFSS) Survey of Florida (2014) using SPSS

Conducted research study to analyze National College Health Assessment (NCHA-2012) dataset to identify strategic public health issues in the USF Tampa community, and worked as a team to develop and present a community health improvement Program, 'PROTECT- A- BULL' to improve safety at night at the USF Tampa campus using the MAPP planning model

Conducted research study to evaluate and analyze the opportunities for physical activity in the Tampa-33612 community in accordance to Physical Activity Resource Assessment (PARA) instrument and protocol

Wrote literature review on the ‘Health effects of Asbestos exposure, conducted expert interview and prepared policy brief on the same

Presented at USF, College of Public Health on the topic ‘Healthy People 2020 objective - Tobacco Use’

Prepared an Outbreak intervention plan by using Ebola Simulator

Participated in a group-debate at USF, College of Public Health against ‘Safe Injection Sites

Applied biostatistical methods in experimental and observational study designs, formulated research problems and interpreted statistical results using Statistical Analysis tools including SPSS and SAS.

Clinical Research Coordinator, Full-time Jul 2018-Jan 2019

Apex Clinical Research, 10549 N Florida Ave, Tampa, FL-33612

Apex Clinical Research is a dedicated, high quality multi-specialty clinical research center located in the Tampa Bay Area.

Administratively and clinically managed 3 phase III clinical trials, adhering to Research SOP’s, ICH GCP, and study specific protocols

Recruited, evaluated, and enrolled patients for participation in clinical research trials

Scheduled patient visits and procedures consistent with protocol requirements and assist PI/sub-I in screening and consent procedure

Created, organized, and maintained all study materials, including, source documentation, case report forms, medical records, regulatory documentation, and serious adverse events

Oversee adherence to study protocol for clinical patient evaluations, treatment administration, questionnaires/diaries and collection, processing, and shipping of biological specimens

Interface with various drug sponsors and clinical research organizations across multiple pharmaceutical trials, gained experience with numerous electronic data capture (EDC) and interactive web response platforms

Communicated with study participants in person/on-phone and maintained accessibility to discuss any questions/concerns they may have regarding the study

Scheduled SIV/monitor visits and oversee site set-up prior to monitor’s arrival

Submit patient reimbursement requests at the conclusion of the patient’s participation

HSE Design Engineer, Full-Time Jun 2013- Oct 2016

Technip India Limited, A-4, Sector-1, Noida, India

Technip is a technology driven, environment and safety conscious engineering, procurement and construction (EPC) contractor, serving a range of sectors including oil and gas, fertilizers, chemicals, pharmaceuticals, liquefied natural gas (LNG), metals and mining and associated industries. It has around 38,000 employees and operates in 48 countries.

3+ years of experience in Environmental and Occupational Health domain of Public Health. Worked with internationally recognized client companies including Reliance and Shell on various energy sector projects as HSE engineer/lead engineer.

Planned and developed project schedules, estimated man-hours and formulated technical queries.

Efficient communication with the client, vendors, and third-party contractors.

Reviewed, revised and refined HSE design documents.

Developed and wrote policies and procedures.

Reviewed applicable codes and standards and client documents.

Prepared HSE Design deliverables within schedule while meeting all the statutory regulations and client requirements.

Participated in various in-house safety studies including Hazard Identification studies (HAZID), Hazard and Operability Studies (HAZOP), and Qualitative and Quantitative Risk Assessment (QRA).

Assisted with preparing disaster drills and debriefings of disaster drills.

Assisted with the record keeping system for accidents and near misses in the company.

Advised employees on adjusting their workstations to meet sound ergonomic recommendations.

Performed Job Hazard Analysis (JHA).

Investigated safety-related incidents, analyze findings and provided recommendations.

Provided training to new joiners.

TRAINING & CERTIFICATIONS

Certified in Public Health (CPH) by National Board of Public Health Examiners (NBPHE)

Good Clinical Practice Certification issued by National Institute on Drug Abuse (NIDA) Center for Clinical Trials. Issued on Sept 13th, 2018. Valid until Sept 13th, 2021

HIPAA Privacy training at USF Health (2017-18)

Rave EDC Essentials for Clinical Research Coordinators issued by Medidata Academy. Date of completion Aug 14th, 2018

Advanced Rave EDC for Site Users issued by Medidata Academy. Date of completion Aug 14th, 2018

EDC Inspection Readiness for Clinical Sites issued by Medidata Academy, Date of completion Aug 16th, 2018

SAS SKILLS

Used SAS Import/Export Wizard as well as SAS Programming techniques to Import data from different sources in different formats including Excel, CSV, and database file

Performed various statistical analysis tests including t-tests, Correlation testing, linear/multiple linear regression analysis, ANOVA test, and, logistic regression using, proc ttest, Proc Corr, Proc freq, Proc Reg, Proc anova, Proc logistic

Managing data by handling missing values and duplicate values using Conditional statements and Proc sort procedure

Validated SAS output using proc compare

Generated summary reports using proc mean, proc freq, proc summary, proc univariate etc.

Generated reports using proc report, proc transpose, and proc tabulate

Generated chart and plots using proc chart, proc gchart, proc plot, proc gplot etc

Used Proc Sql and Macros

PROFESSIONAL SKILLS

literature reviews, critical reviews, and professional report writing

Excellent written and oral communication skills

Strong organization and interpersonal skills

Critical thinking & problem-solving skills

Thorough observation skills and a detail-oriented approach

Team player

Microsoft Software packages including Word, Excel & PowerPoint

Statistical Analysis using SPSS, SAS

PERSONAL DETAILS

Name : Varuna Astha

Gender : Female

Nationality : Indian

Date of Birth : Jan 11, 1990

Languages : English, Hindi

Phone : +1-813-***-****

Country of Residence : USA

Address : 13003, Whitestone Drive, Tampa, FL-33617

Visa Status : H4 (Spouse of H1-B), possess H4 EAD

Work authorization in the US : Authorized to work for any employer in the US

REFERENCES

1.Steven Mlynarek, Ph.D., C.I.H.

Professor, University of South Florida, Tampa, USA

Office: CPH 1110

Voice Mail: 813-***-****

Fax: 813-***-****

Email: ********@******.***.***

2.Naresh Nakarani

Clinical Research Coordinator, Apex Clinical Research,

10549 N Florida Ave, Tampa Florida-33612

Phone: +1-346-***-****

Email: ******@********.***

3.Sathish Kumaran S

Deputy Chief Engineer, Technip India Limited, Noida, India

(CFD, Thermal, HSE Design)

Phone: +91-814*******

Email: *********@*******.***

4.Dr. Nehal Siddiqui

Head of HSE Department

University of Petroleum and Energy Studies

Dehradun, India

Phone: +91-963*******

Email: *****@***.****.**.**

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