Clinical Data Coordinator

Yashika Narendra Meisheri, MS, CCRP

**** ******** ***, *********, ** 92833. 858-***-****. *******.*@*****.*** QUALIFICATION SUMMARY

• Driven and compassionate healthcare professional with over five years of experience in clinical research and data management field.

• Assured Good Clinical Practices, investigator integrity, and compliance with all study procedures and investigational product.

• Responsible for the resolution and correction of all database discrepancies to assure consistency of data collection and validation in providing a clean, quality locked databases.

• Excellent track record when it comes to consistent quality and reliability in carrying out research duties according to regulatory guidelines.

CORE COMPETENCIES

• Quick learning curve and ability to work hard.

• Dynamic analytical and management skills.

• Effective communication skill and leadership

qualities.

• Relationship and team building.

• Keen attention to detail and organized.

• Therapeutic areas include Central nervous

System, Musculoskeletal, Cardiovascular,

Dermatology, Oncology, and

Gastroenterology.

• Computer skills include MS office package

(Word, Excel, Powerpoint, Project, Outlook,

Access).

PROFESSIONAL EXPERIENCE

Advanced Research Center, Inc., Anaheim, California, US 10/2015 – 10/2017 Clinical Research Manager

• Effectively handing all the study requirements process from site initiation to study close out.

• Creating and designing electronic and paper source documents per protocol, regulatory and GCP guidelines for multiple clnical trials.

• Efficient conduction of all subject visits at site by ensuring visits are scheduled as per protocol and all necessary prerequisties for such visits are available, reviewed and endorsed by the PI.

• Management, Accountability and Reconciliation of investigational product.

• Performed documenting, reporting and follow-up with adverse events as necessary.

• Commuincate with CROs, sponsors and vendors to ensure all regulatory and sponsor requirements are fulfilled.

• Enter accurate data and timely completion of study data and answering EDC and third party generated queries.

• Perform Quality check of completed source documents and prepare site for monitor visit and external/internal audits.

ICON Clinical Research, Trivandrum, Kerala, India 04/2014 – 06/2015 Clinical Data Coordinator I

• Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings. Accurately generate data queries to resolve data discrepancies.

• Accurately perform Serious Adverse Event reconciliation and external data reconciliation in accordance with all applicable procedures.

• Participated in close-out activities and database finalization.

• Adhered to study lock and interim analysis timelines for successful completion of assigned tasks.

• Generate, review for accuracy and distribute status reports as requested.

• Recognized by Senior Department Managers for superior performance and assigned to support other departments with tight deadlines.

• Successfully trained Site Coordinators for proper understanding of DM concepts, mentored new team members, performed Peer Review.

ICON Clinical Research, Trivandrum, Kerala, India 10/2012 – 03/2014 Assistant Clinical Data Associate

• Accurately review Case report form data for completeness, accuracy and consistency in accordance with all applicable procedures.

• Reviewed protocols, standard operating procedures (SOPs) and validation guidelines.

• Generated queries and updated the database with resolutions.

• Received Organization Spot Award in 2013 and Performance based bonus in 2014. Lotus Labs Pvt. Ltd, Bangalore, Karnataka, India 03/2011 – 09/2012 Executive – Data Management - Clinical Reporting

• Preparation and documentation of Clinical Study Reports that are clear, concise, scientifically as well as medically accurate, and fully compliant with all applicable ICH and regulatory guidelines, with submission reports provided in eCTD and CTD formats.

• Good understanding of bioanalytical, pharmacokinetics and statistical analysis. EDUCATION, CERTIFICATIONS AND TRAININGS

• Certified Clinical Research Professional (SOCRA CCRP® )

• GCP, GCDMP, GMP, GDP, 21CFR Part 11, FDA and ICH regulatory guidelines

• Electronic Data Capture (EDC) tools include Oracle clinical RDC, iMedidata RAVE, INFORM, TrialMaster, IBM, DataLabs.

• Interactive Web Response System (IWRS) – Clinphone, Suvoda, Veracity Logic, i360 user, Bracket

• Programming SAS certification.

• California University of Management and Science, Anaheim, CA Master’s in Healthcare Management, May 2018

• Mahatma Gandhi University, India

Master of Science: Biotechnology, 2008

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