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[QUOTE=shaileshpatil;178660]Shailesh Kashinath Patil
E-mail – shailesh.mhrc AT gmail.com 
 
¬¬¬¬¬¬¬¬¬¬¬¬¬¬¬ 
Power Statement
To obtain a position that will utilize my talent and potential to meet the goals of the organization and provide me personal and professional growth in clinical research.
Experience
[b]Name of organization [/b]: Mehta Hospital and Clinical Research Centre, Ahmedabad
[b]Duration  [/b]: Oct 2009 – Till Date
[b]Designation  [/b]: Clinical Research Coordinator
[b]Responsibilities  [/b]: Perform Service at the Investigator Site in accordance with ICH GCP guidelines, 
 Applicable Local Regulatory and EC requirements and the approved study Protocol. 
- Prepare & Review document For EC communications.
- Prepares for and assist at the Site Initiation Visit, Interim monitoring Visit and the Close out visit.
- Maintenance of ISF and other trial related study documents.
- Completion of CRFs/eCRF, From the Source Documents with ensuring accuracy of all records.
- Review completion of all protocol related procedure /assessments by the responsible Investigator, which would include scheduling, Subject screening and Enrolments.
- Assist timely resolution of Data Clarification Forms/ Data Queries.
- Maintain Study Inventory of all the Clinical trial supplies including, Lab Kits and Study Medication and Study Documents.
- Documenting an Adverse Event and Reporting to Sponsor, IRB/IEC.
- Perform any other study related co-ordination function as required by specific protocol or assigned by the Investigator.
- Ensure that the Investigational Product (IP)’s are stored at required temp and maintain the IP Accountability log.
Project Summary
Sr. No. Indication of Trial Clinical Phase of Trial Role in Trial Year in Which Trial Was Conducted
1. Idiopathic Pulmonary Fibrosis III Study Coordinator Dec 2011 to ongoing
2. Acute Bacterial Skin & Skin Structure Infection III Study Coordinator Dec 2011 to Ongoing
3. Invasive Fungal Infection IV Study Coordinator March 2011 to ongoing
4. DM type-2 III Study Coordinator Jun 2010 to Nov 2011
5. Asthma IV Study Coordinator Jan 2010 to Dec 2010
6. DVT (Deep Venous thrombosis) III Study Coordinator Oct 2009 to Aug 2011
7. AF (Arterial Fibrillation) III Study Coordinator Oct 2009 to Dec 2010
Area of Interest
- Clinical Research Associate
- Clinical Trial Assistant
 Academic Credentials
2009 PG Diploma in Clinical Research Affiliated by ACRP, from Bilcare Research Academy, Pune, (MH).
2008 B.Sc. in (Microbiology), from North Maharashtra University, Jalgaon, Maharashtra.
2005 Diploma in Medical Laboratory & Technology from MTRI, Pune, Maharashtra.
Computer Skills
 
Microsoft Operating System, Internet – Proficient.
Certificate Program
- Successfully completed the NIH Web-based training course “Protecting Human Research Participants”. On 26/Mar/2010
- Successfully completed Quintile GCP Module (1 to 6) of Certificate of Completion on 15-Jul-2010. 
- Successfully completed CAPA (Corrective And Preventive Action) on 01/Aug/2010 
- Completion of PPD Electronic Data Capture Training OC RDC (Site)-(4.5.3.) on 04 July 2010 and 16 Sep 2011
- Completion of ICH GCP web based training of Royal Holloway University of London. On Aug 2010 
- Successfully Completed RDC onsite Web Based Training (BI) on 17 March 2011.
Workshop Attended
 
- Attended workshop on clinical drug trial with special reference to RA/OA knee on 14th Nov. 2008 organized by Indian Rheumatology Academy at Pune.
- Attended ICH-GCP training and Clinical Research Site Coordinator course From “Safe Search Independent Ethics Committee” (SSIEC) From Ahmedabad on 01/Dec/2009.[/QUOTE]

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