JITEN PATEL, CCRP

Email: wbqvgn@r.postjobfree.com 10763, 100 Street, Ozone Park, NY 11417 Ph: 646-***-****

Objective: Results-driven, solutions-focused and detail- oriented professional desiring a challenging and rewarding position of Research 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.

PROFESSIONAL SUMMARY:

• Excellent 4+ years of Clinical Research experience

• Excellent 1 years of R & D experience

• Deep knowledge of monitoring procedures.

• Experience with Phase I clinical trial.

• Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements.

• Disease experience: GI

• Highly proficient in all time management aspects, including quickly identifying and completing priorities in a proactive and productive manner.

• Skillful at performing within a team-based environment to meet and/or exceed all operational goals and objectives.

• Excellent Troubleshooting and problem-solving skills.

• Possess effective communication, problem solving, analytical and leadership skills and willingness to learn and master a new technologies quickly.

• Excellent Analytical, Communication, and Team Working skills.

• Highly experienced in Effort Estimations, Detailed Analysis of Business requirement mapping those to technical Requirements.

• Strong work ethics, good time management skills, establish and maintain productive working relationship with management, Clients and team members.

PROFESSIONAL EXPERIENCE

Vijaypal Arya Physicain PC, NY (Clinical Research Associate) 02/2008- Present

• Designing the registration of clinical trials/studies protocols

• Protocol and Informed consent form drafting and submitting to IRB.

• Ensuring the implementation of project plans as assigned.

• Manage the Trial Master File (TMF) for multiple trials ensuring all essential documents are tracked and filed in accordance with ICH/GCP guidelines.

• Responsible for site monitoring, site management, site administration and registry management for clinical studies according to GCP, ICH Guidelines

• Monitor the clinical trial progress ensuring that it is recorded, conducted and reported in accordance with SOPs, protocol, GCP/ ICH and 21 CFR and the relevant regulatory requirements.

• Prepare, collect and review all essential site documents throughout the study lifecycle

• Provid study training, administer protocol and ensure understanding of appropriate SOPs, ICH-GCP guidelines to assigned site.

• Preparation of informed consents and Ensure/Audit Authorization (Consent) Forms has been completed and are kept in patient file.

• Data collecting, documenting, analyzing and resolving data discrepancies by ensuring complete and accurate data by reviewing source documents.

• Documentation of adverse event

• Write internal reports, documents and preparation of abstract/manuscript

• Participate in team meeting including data presentation and problem solving.

• Patent filing, trademark application, Grant Writing

• Participated in the preparation of an NIH R21 grant.

• Active involvement in the statistical considerations of the study

Claris Life sciences (India) (R&D Formulation Officer) 01/2007 – 12/2007

• Batch Formulation and Preformulation of Parenteral Fat Emulsions (Lipid Drug Delivery Systems) to manufacture Propofol.

• Operating instruments HPLC, HPTLC and Emulsifier.

• Experimentation for Method Development stage wise

• Compilation of stability data

• Stability sample analysis of previously completed projects.

• Validation of analytical methods.

• Method development progress report and presentations

• Maintenance of lab, equipments as per GMP/GLP regulations related to laboratory.

• Preparation of test methods and method validation report.

• Execution of work for analytical related regulatory queries.

RESEARCH AND PUBLICATIONS:

Peer Reviewed Abstract:

1. Arya, V.; Gupta K.A.; Arya, S.; Patel, J.; Valluri, A. Total Intestinal Perfusion Study with Yoga (Shankh Prakshalana). American College of Gastroenterology, Annual Scientific Meeting, Washington DC, 2011. P 941.

2. Position change for optimal Cecal base visualization: A Prospective study – American College of Physicians Meeting. Toronto, 2010

3. Efficacy of Bolus Lukewarm Saline and Yoga (Shankh Prakhshalana) as Colonoscopy Preparation – Interim Analysis of Randomized, Endoscopist Blinded Study – American Journal of Gastroenterology, Vol. 105, Supp. 1, S146, October 2010.

4. Effect of Yoga (Shankh Prakhshalana) on Liquid Gastric Emptying Pattern Measured By Real Time Ultrasound – American Journal of Gastroenterology, Vol. 105, Supp. 1, S44-S45, October 2010.

SKILLS: Entrepreneurial vision, communication skills, decision making, Analytical, Bioanalytical Instrument

operation, Microbiology, Molecular Biology.

COMPUTER SKILLS: Microsoft Office, including Access and SharePoint systems, Adobe Photoshop, Illustrator

CERTIFICATION:

Institute Course Date of Completion Certificate Number

SoCRA Clinical Research Professional 10/28/2011

NIH Protecting Human Research Participants 08/19/201*-******

NIH Clinical Research Training 08/19/2011

HIPAA training 8/22/2011

CITI-Biomedical Research-Basic 8/22/201*-*******

EDUCATIONAL QUALIFICATION:

College and Degree Completion date G.P.A

Masters in Biotechnology & Entrepreneurship Dec, 2009 3.8

Polytechnic Institute of NYU, Brooklyn, NY

Bachelor of Pharmacy May, 2007 3.2

BMCPER, Modasa, India

References available upon request

Contact this candidate