Clinical Research Medical

Professional Summary

Seeking a Clinical Research Associate position in the medical field while merging into a globally focused organization that will purposefully utilize my qualifications, while offering several opportunities to integrate personal enrichment with professional goals.

KEY EXPERTISE AND COMPETENCIES

In-depth knowledge of Clinical Research Fundamentals, Medical writing documents such as protocol, CSRs, IBs, ICF.

Knowledge of Regulation of Drugs, Biologics and Medical Devices and Diagnostics application including NDA, ANDA, PMA, and PMN

c Good Clinical Practice and ICH

Project Management

Resource Management

Site Monitoring; initiation to close out

Preparation, review of Clinical reports

ICF Presentations & Obtaining

FDA, ANVISA, EMEA, In-house audits

Review of Regulatory documents, CRF

Strategy Planning

Quality Management System

Aggregate Safety Reports

Secondary Research

Pharmacovigilance System

Client Communication

PROFESSIONAL EXPERIENCE

Santa Clara Valley Medical Center, Santa Clara, CA 02/2015 – 04/2015

Clinical Research Volunteer

Performed review of clinical and pharmacy data of patients.

Ranbaxy Research Laboratories, Delhi, India 05/2008 – 09/2013

Clinical Research Associate

Responsible for conducting end-to-end project management for sponsor-initiated clinical research studies.

Prepared and reviewed various clinical documents such as protocol, CRF, informed consent, adverse event recording sheets for completeness and accuracy.

Coordinated, and reviewed regulatory study documents at start-up.

Site Monitoring and managing clinical issues through the entire duration of the study till close out.

Involved with data processing and site management for assigned studies.

Ensuring timely communication with different departments for optimal conduct and submission of clinical studies to various regulatory authorities.

Confirming protocol compliance, assessing qualifications and relevant training of study personnel, and ensuring Good Clinical Practice and Good Laboratory Practice.

Participated in QA/QC process as “bench” quality personnel for critical review of various clinical data including adverse events, case safety narratives, and SAEs.

Facilitated in-house and audits by regulatory agencies (WHO, USFDA, EMEA, ANVISA,DCGI and IRB).

Reconciled and maintained Trial Master Files and Regulatory Binders.

Reviewed trial documents for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, Standard Operating Procedures (SOPs), and sponsor requirements.

Managed the study drug accountability and storage, and create study specific data tracking tools.

Coordinated with the Principal Investigator for submitting the study related documents to Institutional Review Board (IRB)/ethics committees (EC) and obtaining approval for protocols, informed consent forms (ICFs) and case report forms (paper CRFs & EDC).

Prepared and amended SOPs and working instructions as per the need and maintained awareness of and adherence to all current SOPs.

Critical review of compiled raw data, complete reports, SAE and related documents during and before final submission to regulatory authorities.

To liaise with various verticals of company and with documentation scientist for smooth conduct of the project.

Coordination with various vendors for timely delivery and with foresight.

PROFESSIONAL DEVELOPMENT

Syngle; K. Vohra; L. Kaur; S. Sharma: Effect of spironolactone on endothelial dysfunction in rheumatoid arthritis, Scand J Rheumatol, 2008, First Article, 1–8.

Arora Tarun; Anand Gaurav; Sharma Sumeet; Gupta Nakul; Tandon Monika: A Pharmacodynamic Pilot Study to Evaluate the Effect of Gatifloxacin and Glyburide Alone and in Combination on Plasma Glucose and Serum Insulin Levels in Healthy Human Subjects. IJRPS 2011,1(2), 43-56.

S. M. Abdullah; T. Arora; G. Anand; S. Sharma; M. Tandon; N. Saha: Clinical Evaluation Of Imidapril and Lercanidipine Using Abp Monitors Among Essential Hypertensive Subjects. Int J Xeno Pharm Tech 2011:1(3) 65- 69.

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EDUCATION & CERTIFICATION

Master of Pharmacy, Punjabi University, Patiala, India 2007

Bachelors of Pharmacy, CCS University, Meerut, India 2003

Clinical Trial Design and Management, UCSC Silicon Valley Extension, San Jose, CA 06/2015

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