Clinical Research Data

JANVI B. SHAH

adffcc@r.postjobfree.com +1-619-***-**** linkedin.com/in/janvishah21

EDUCATION

●UNIVERSITY OF CALIFORNIA, SAN DIEGO

MAS (Master of Advanced Studies), Clinical Research (GPA- 3.6/4) Expected September 2020

Concentration in Translational Sciences

● SPPSPTM, NARSEE MONJI INSTITUTE OF MANAGEMENT STUDIES, MUMBAI, INDIA MBA (Master of Business Administration), Pharmaceutical Technology May 2019

● SPPSPTM, NARSEE MONJI INSTITUTE OF MANAGEMENT STUDIES, MUMBAI, INDIA Bachelor’s in Pharmacy May

2019

CERTIFICATIONS-

Adult, child and infant CPR and AED Training (BLS). American Health Care Academy

Human Research Data or Specimen Only Research 1-

Basic Course.

Collaborative Institutional Training Initiative (CITI) Research Aspects of HIPAA.

University of California San Diego – Human Research Protection Program.

Biosafety: Bloodborne Pathogens Training.

University of California San Diego.

SKILLS

● Clinical: Biostatistics, Data Analysis, CDMS, Clinical Trials, SOPs, CRFs, ICFs, IRBs, Phlebotomy(derma puncture), Clinical Research, Data Collection, Study Protocols, Electronic Data Capture, Patient care.

● Technical: IBM SPSS, G Power, SAS, R programming language, MySQL, Smartsheets, Microsoft Office, Adobe. EXPERIENCE

Research Intern, Department of Anesthesiology, Division of Biological Sciences. UNIVERSITY OF CALIFORNIA, San Diego January 2020 – June 2020

● Performed cholesterol quantification from total membrane extract and membrane subfraction samples of mice using ELISA and colorimetric assay (Amplex Red).

● Performed experiments of isolation of cellular membrane and membrane fractioning by ultracentrifugation, time-lapse microscopy for staining the cells, neurons, and fibroblasts with cholesterol-BODIPY.

● Cultured approximately 25 patient skin explants.

● Assisted in collecting serum cholesterol concentrations from mice. Research Coordinator – Clinical Research September 2017 – May 2019

Aggarwal Eye Hospital and Lasik Center, Mumbai, India

● Coordinated study start-up, execution, and close-out of Phase I-IV industry sponsored trials across the therapeutic areas of ophthalmology and oncology.

● Maintained Source Documents, CRFs, Investigator site files, and other study-related documents according to ICH/GCP guidelines.

● Prepared and conducted site selection, site initiation visits, on-site monitoring visits, and close-out visits for about 15 trials.

● Upheld proper documentation according to protocols, regulatory requirement, and company SOPs, including all assigned trial master files.

● Completed eCRFs, review forms, and submitted all study-related documents to IRB.

● Carried out all procedures required for the study, including but not limited to health assessment, electrocardiograms, phlebotomy(dermal puncture), blood processing, glucose monitoring and obtaining vital sign readings.

● Supported external relationships with sponsor and CRO contacts and clients to develop and maintain collaborative working relationships and grow business.

● Documented and reported adverse events, specifically prompt and proper SAE submissions and follow-up.

● Proactively developed and executed recruitment plans that met and exceeded goal in the amount of approximated $2000 a month.

● Actively engaged in recruitment activities such as developing and implementing advertisements, cold calling potential study participants, developing database and creating phone screeners.

● Maintained retention rate at 80% and increased the awareness and patient enrollment rate by 30%.

● Successfully met every recruitment goal resulting in 100% studies either closing on time or earlier than predicted. PROJECTS-

Kidney function in HIV preexposure prophylaxis men treated with Truvada with and without Vitamin D. June 2020 - Current Performing cleaning and merging of data received from a previously conducted Clinical trials and then statistically analyzing the data to address the above research question as a part of my final ISP thesis. Tools used- Microsoft excel – VBA, SPSS, and R.

Use of Cannabis in chronic pain- Opioid tapering effects. October 2019 – May 2020

Performed a retrospective chart review of patients with chronic pain and on opioids with and without a cannabis prescription. The data was abstracted from the EPIC system. The data was then collected in the REDCap database, where the data was cleaned and prepared for analysis.

Tools used- REDCAP database, Excel – VBA.

Myo-Inositol and D-Chiro Inositol Compared to Hormonal Contraceptives for Reduction in Ovarian Cysts in Overweight and Obese Women with Polycystic Ovary Syndrome. September 2019 - March 2020 Designed and drafted a concept proposal for a randomized controlled trial to address the above research study. Designed and drafted an Informed Consent Form (ICF) and Institutional Review Board (IRB) proposal submission for the above designed randomized control trial.

The role of Adiposity on Osteoporosis in Men. September 2020 - December 2020 Used the MrOS study which is an NIH funded prospective observational study from 6 centers across the United that collected data of over 41,000 variables from 5,994 men older than 65 over a period of 16 years to address the research question – to determine whether visceral adipose tissue (VAT) is positively associated with low bone mass and to determine whether the relationship between VAT and BMD will differ based on thyroid function (hypothyroid vs normal thyroid function vs hyperthyroid). Tools used- SAS, SPSS, R programming language.

Contact this candidate