Name: Mehta, Devang

Office Location: ***** Noltland Castle Drive, Bristow, VA 20136

Position: Sr. Clinical Research Associate

Summary

Devang Mehta, Sr. Clinical Research Associate, has been working in Clinical Research since 2002. Prior to joining Quintiles, he held positions as a Clinical Research Associate and Clinical Trial Associate.

Dr. Mehta has served as a CRA on studies in the following therapeutic areas: diabetes, ADHD and Parkinson’s Disease with movement disorders. He also served for two years on the LSFR group working on Oncology trials with solid tumors. Dr. Mehta has experience in Phase,II, III, IIIb and IV clinical trials from study start up through database lock including monitoring and query resolution.

In addition to his field experience, Dr. Mehta has experience in reviewing regulatory documents, query resolution, informed consent review, and site invoicing.

Responsibilities are summarised below

X

Feasibilities

X

Initiation visits

Audits

Investigator Meeting Preparation

X

Monitoring visits & SDV

Inspections

X

Attendance to Invest Meetings

X

Closure visits

Submission dossier

Delivery of GCP trainings

X

Query resolution

X

Collection of regulatory packages

Submissions to Regulatory body

X

Drug accountability

Submissions to Ethic committees

X

Management of SAEs

X

Re-labelling process

X

Site Selection visits

Manage Central Clinical Files

Newsletter Production

Provide Clinical Trial Assistance

‘Second Scrub’ CRF Review

X

Enrolments Tracking

X

Management of IP/Study Supplies

X

Site Communication

X

Co-monitor/in-house monitor

Education / Qualifications

Date

Place of Education

Degree/Qualifications

1995

St. George's University School of Medicine Grenada, West Indies

Medical Doctor

1990

City College of New York

Bachelor of Science, Biology

Employment History

Employer/From – To

Roles & Responsibilities

Novartis March 2017- August 2017

Senior CRA working in multiple projects for the purpose of conducting site selection visits. Conducted presentation. Numerous trials in cardio-metabolic metabolic therapeutic areas.

PRA- May 2014- Aug 2016

Sr. CRA: Diabetes trial, Asthma trial, Multiple Sclerosis trial, Pompe trials, part of lysosomal storage disease.

ICON April 2012 -April 2014

SR. CRA: Psoriasis study a phase 3: blinded and open label.

Dyslipidemia study

Lsfr/ Amgen/quintiles 2007-2012

Senior Clinical Research Associate Level 2 and level 3

Oncology exposure:

Denosumab trial with colorectal indication phase 3 trial.

Neulasta trial involving Febrile neutropenic subjects phase 2b

Enbrel study phase 4 for psoriasis

Pediatric Enbrel for psoriasis Phase 3

Denosomab on post menopausal women for osteoporosis phase 3

Phase 4 observational study regarding practicing habits of a small dialysis unit and the prospective changes in Medicare.

2-3 (Long term Follow up studies.

Senior Clinical Research Associate

Provide monitoring visits and site management for a variety of protocols that are complex and/or require knowledge in advanced therapeutic areas

Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager

Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation

Act as a mentor for new clinical staff and may provide assistance to the CTL as designated

Clinical Research Associate

Performs clinical monitoring in compliance with FDA regulations and all related SOPs. Monitoring visits include evaluation, selection, and initiation, interim and close out visits. Instructs the investigational site staff in their roles and responsibilities in conducting clinical studies and evaluates site performance and compliance in conducting clinical studies. Monitors regulatory status of studies at sites. Coordinates collection of information from investigational site. Participates in investigator meetings. Completes trip reports and is responsible for all communication with sites.

Monitoring-Force USA Washington, DC

October 2005 – August 2006

Clinical Research Associate

Responsible for monitoring all types of monitoring visits to ensure that investigator and research staff conducted the clinical study in adherence with all protocols, and regulations.

Maintained drug accountability verified source documents, verified and collected regulatory documents, and generated queries.

Managed data flow process related to data review, query resolution and CRF collection and retrieval and processing.

Monitored and tracked SAEs for the US and Canada.

Managed the processing of SAE information received from investigators including review, clarification, and interactions with monitors, sites, Drug Safety, and Clinical Science.

Responsible for completing monitoring visit reports and meeting deadlines.

PAREXEL International Centreville, VA

November 2002 – July 2005

Clinical Trial Associate III

Conducted study start-ups and interacted with Principal Investigator on medical issues for clinical studies.

Resolved queries, reviewed protocol, assured drug supplies were received and accounted for.

Reviewed and reported SAEs per SOPs.

Monitored patients undergoing a pharmacological stress test and recorded outcomes. Helped develop the Quality Assurance Scans for managers to monitor CTAs.

King Teleservices, Inc.

Long Island City, NY

February 2000 – May 2002

Account Manager

Managed a staff of 30 people.

Produced daily, weekly and monthly reports

D.F. King (Parent Co. of KTS)

Long Island City, NY

July 1999 – February 2000

Quality Assurance Supervisor

Responsible for reporting averages of weekly scores for clients' monitors

Adhered to TCPA regulations.

Conducted weekly calibration sessions. Coached and counselled monitors as needed.

King Teleservices, Inc.,

New York, NY

March 1998 – May 1999

Quality Assurance Manager

Responsible for the day to day activities of the Quality Assurance Dept. Maintained high quality standards as per TCPA along with legal, ethical, and client specific guidelines.

Created the Quality Assurance program for the KTS training manual. Facilitated the QA training sessions. Tracked inventory and supplies.

Generated employee database with 400 entries.

Jewish Home & Hospital

New York, NY

November 1997 - February 1998

Medical Assistant for Ambulatory Clinic

Responsible for taking medical history, drawing blood, performing EKG and general office filing.

NYU Medical Center

New York, NY

November 1996 – June 1997

Research Assistant

Responsible for data entry; calculated patency rates of vascular grafts.

Brookdale Hospital

Brooklyn, NY

June 1996 – September 1996

EKG Technician

Pre-operational Unit in Paediatrics Department

Dr. Dhanjal, MD

Queens, NY

June 1986 – June 1987

Medical Assistant

Venipuncture, EKG, stress test, U/A, Throat Cultures

Project Experience in Quintiles

Project description

Description of Responsibilities/Tasks

Including start and end dates

Phase

Indication

&

Drug class

III

Dysfunctional Central Venous Access Catheters

Clinical Research Associate September 2006 – September 2008

III

Device study for allergy/asthma, Solid tumour trials with TGFi.

Clinical Research Associate February 2008

Systems Experience/IT Skills

PC Skills: MS Word, Excel, PowerPoint, Lotus Notes, InnTrax (Clinical Trial Management System), E-clinical, MediData Rave.

By Tgb

Other Relevant Details

Medical rotations completed in Luton & Dunstable Hospital, Norfolk and Norwich Hospital England (12 week rotations each in paediatrics, surgery, and internal medicine, and six weeks each of OB/GYN and psychiatry)

Medical Research Management - Fundamentals of Clinical Research - October 2005

Georgetown University/Barnett International, 2004

Completed Clinical Research Associate and Clinical Research Coordinator Course

Parexel International Training

HIPAA, Time Management, Adapting to Change, ongoing CRA training courses.

Internship for Computer Programming Mondial Ltd. New York, NY January 1998 – February 1998 Programmed in VB 5.0 using GUI development. Tested and documented in-house applications.

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