Clinical data coordinator

RUTVA TRIVEDI

LinkedIn: www.linkedin.com/in/rutvatrivedi/

*************@*****.***

Objective: To acquire a position in healthcare organization that offers

professional growth and development, utilizing my skills from

both academic and business sectors.

Experience Summary:

External data reconciliation, DCF review, data audit and UAT

on multiple studies

Discrepancy management including discrepancy review, query

generation and updating

Review CRF/eCRF and Train new team members

Run daily Ad-hoc reports to track open/answered queries

Enter test data and assist to create test data for data

validation

Experience working in both EDC and paper based systems for

Phase I/II/III studies

Therapeutics areas include Neurology, Cardiovascular,

Oncology, Orthopedics

Contribute in all activities from study startup to database

lock

Work with SAS programmers, Medical reviewers and

Biostatisticians to update listings and resolve data issues

Run routine reports to check data quality

Familiar with creating and review process of CRF design, edit

checks, study protocol and SAE reconciliation

Verify that clinical data recorded is complete, accurate and

consistent

Critical QC Audit/Critical Variable QC as needed

Serve in the role of back-up to Data Operations Coordinator

(DOC)

Efficiently work under tight deadlines and on multiple

projects

Self-learner and result oriented

Effective time management and excellent problem solving

skills

Effectively work in cross-functional teams and independently

Excellent interpersonal, verbal and written communication

skills

Maintain a high degree of flexibility in a fast-paced study

environment

Detailed knowledge of clinical trials methodology, medical

terminology and ICH/GCP regulations

Familiar with Clinical research guidelines, MEDRA and WHOART

dictionaries

Learned to develop test procedures (IQ/OQ/PQ), test protocols

and computer system/instrument validation during MS in

Validation and Regulatory affairs

Extensive knowledge of Pharmacology and Pharmaceutics

Knowledge of FDA and international regulations governing

current GCP/GLP/GAMP and new electronic requirements such as

21 CFR Part 11

Software/IT Skill:

Inform 4.6

Fortis 2.2

Medidata Rave 5.6.2

OC-RDC

MS office word, excel and power point

Microsoft Outlook

Related work experience:

Quintiles, Overland Park, KS, USA 10/2012-Present

Clinical data coordinator (contractor)

Extensive experience working on listings i.e. AE, CM,

Dose/IVRS, Diary, ECG, Lab data

Reconcile data discrepancies and complete clean-up processes

on multiple studies

Run macro application on listings

Propose new approaches for discrepancy resolution

Exercise excellent attention to detail on each assignment

Quintiles, Overland Park, KS, USA 10/2010-06/2012

Clinical data coordinator (contractor)

Review listings, resolve manual and system generated queries

Enter test data for listing validation in QC database

Assist in creating test data using external data per study

requirement

Review Ad-Hoc reports, BIOS listings and Exception reports

CVS/Caremark Pharmacy, Overland Park, KS, USA 07/2010-10/2010

Pharmacy Technician

Assist pharmacist in patient's prescription filling process

Assist in all third party transactions along with completion

of required paperwork

Communicate and help customers with their questions and

concerns on the phone and in person

Multitasking and work with precision and efficiency

Stevens Institute of Technology, Hoboken, NJ, USA 01/2009-05/2009

Teaching Assistant

Work accurately on assigned tasks including reviewing quizzes

and assignments

Assist professor in arranging lectures and exams

Provide guidance to students in the program regarding course work, study related assignments and project work

Education:

Stevens Institute of Technology, Hoboken, NJ, USA 01/2008-12/2009

Master of Science in Pharmaceutical Manufacturing; GPA: 3.8

North Gujarat University, Modasa, Gujarat, India 06/2003-06/2007

Bachelor of Pharmacy; GPA: 3.9

Certification

Graduate Certificate in Validation and Regulatory Affairs,

USA

Graduate Certificate in Pharmaceutical Manufacturing

Practice, USA

Certified Pharmacy Technician, USA (Certification #

5001-0701-0051-899, from 12/2009 to 03/2012)

Licensed Pharmacist, Gujarat State, India

Graduate Certificate in Bachelor of Pharmacy, India

Available to relocate

Contact this candidate