Vrushangi Patel
*** ***** ******, ******, ** – **018
Email id: acw5q2@r.postjobfree.com
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
PHARMACY TECHNICIAN
May 2015- March 2016
Responsibilities:
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
Responsibilities:
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
Responsibilities:
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