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Clinical Research Associate

Ridley Park, Pennsylvania, United States
October 20, 2016

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Vrushangi Patel

*** ***** ******, ******, ****018

Email id:

Cell Phone: 302-***-****

Objective Statement

To work as a Clinical Research Associate with a Clinical research organization and handle the documentation, preparation, and deliverables of Clinical trials. Summary

Creative Clinical Research Associate with extensive experience from concept to development with 4+ years’ hand on experience in developing and presenting trial protocols.

Maintained Trial Master File, Batch records, Informed Consents and study metrics. Ensure compliance of ongoing trials to protocols, FDA and GCP.

Talents include in-depth knowledge of ICH guidelines, SAE reporting and GCP auditing. Well versed in liaising with Health care professionals.

Profound Know how of handling, filing and collating duties to manage appropriate documentation. Highlights

Medical Terminology

FDA regulations and ICH Guidelines

MS Office

Profound knowledge of GCP, cGMP and GDP

21 CFR 210, 211, 820 and 11

Guidance documents and Warning letter

FDA issued form 483s

IND, NDA and ANDA applications

Patient counseling, prescription filling, inventory management, assisting manager and record keeping

Capable of working both independently and in a team-oriented working environment

Excellent oral and written communication skills.

Possess solid researching skills, analytical thinking, problem solving skills and positive attitude

High level of familiarity with Excel, Word, Visio and powerpoint PROFESSIONAL EXPERIENCE

Rite Aid Pharmacy, Secane, PA


May 2015- March 2016


Helped health care providers and patients by greeting them in person and by phone; answering questions and requests, referring inquiries to the pharmacist.

Maintained pharmacy inventory by checking pharmaceutical stock to determine inventory level.

Maintained a safe and clean pharmacy by complying with procedures, rules, and regulations.

Protected patients and employees by adhering to infection-control policies and protocols.

Organized medications for pharmacist to dispense by reading medication orders and prescriptions; preparing labels; calculating quantities and other pharmaceutical therapies.

Maintained records by recording and filing physicians' orders and prescriptions.

Ensured medication availability by delivering medications to patients and departments.

Prepared reports by collecting and summarizing information.

Contributed to team effort by accomplishing related results as needed. Intas Pharmaceutical Company, Ahmadabad, Gujarat, India CLINICAL TRIAL ASSISTANT

January 2012 – May 2014


Communicated with sites regarding trial start-up, conduct, and close-out activities

Collected and reviewed regulatory documents from clinical sites

Initiated, maintained, and reconciled Trial Master Files

Organized and maintained tracking systems and tools to support the conduct of a clinical study from start-up to close-out

Maintained accurate tracking and reporting of study metrics

Coordinated communication of tracking information between Clinical Operations and vendors

Performed job duties with minimal guidance

Provided support to Clinical Operations Management and CRAs

Reviewed ICFs and monitoring visit reports for protocol deviations and study status

Assisted with study archival of training records for FDA audit preparation

Assisted with audit reports and organized site visits for senior associates

Conducted account reviews and reconciled financial reporting

Planned and implemented procedural changes to increase effectiveness and productivity

Reviewed trip reports and assisted in resolving conflicts

Responsible for ensuring monitor completes project related activities and redesigned filing structures

Jivraj Mehta Hospital-Retail Pharmacy Store, Ahmadabad, Gujarat, India TRAINEE PHARMACIST

April 2011 – January 2012


Patient Counseling: Help patients understand how to take drugs, when to take.

Stalk maintenance and collection.

Redesigned workflow for mail-order pharmacy operations to reverse prior history of lost prescriptions.

Recognized for ability to manage a high volume of patient accounts. Consult with hundreds of physicians and patients to fill prescriptions, review side effects, discuss drug interactions and resolve medication delivery problems.

Improved drug-inventory management system to reduce waste and eliminate back orders. EDUCATION

Master of Science (PHARMACY) QA/RA,

Temple University, Philadelphia, PA

Courses taken:

Drug Development

Food and Drug law

Quality Audit

Good Clinical practices

Current Good manufacturing practices

Unit Operations

Clinical trial management

Pharmaceutical marketing

Clinical aspects for Pharmaceuticals

Bioethics for Pharmaceutical professionals

Bachelor of Pharmacy,

CHARUSAT University

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