Objective :
To be a strong global player and the front runner in this race which happens to be the booming industry of Clinical trials & study taking over the world and energize this growth with high resolute Quality and Ethical study data with compliances to GXPs.
Current Employer :
Best Quality service provider Icon - Quintiles Research (India) Pvt. Ltd., is a global Clinical Research Organization who has accomplished 25 years globally and 10 years in India. Joined in as Associate Site Start-up Specialist from May 2008.
My Job description includes :
1. Site / Investigator Identification & selection through contact & acquiring Site’s / Investigator’s Information.
2. CTA/Budget negotiation.
3. Updating project specific soft wares such as Clinical Informatics, Informant & Intraxx.
4. Ethics Committee Contact & submission,
5. Regulatory Authority Submission.
6. Responsibility to review the Informed Consent Form; carry out essential verification & further study specific language translation.
7. Reviewing & Filling of all site specific documents & maintaining a Central Clinical File (CCF) for further proceeding to Initiation.
8. Ensure study progress is according to timelines, budget and quality standards and provide update to the planning and operational coordinator accordingly.
9. Arrange for all necessary center payments as per financial agreements.
10. Contribute to identification and evaluation of new centers suitable for conducting Clinical research.
11. Participate in internal initiatives and contribute to continuous improvement process.
12. Act as mentor to new Clinical Research associates as required.
Previous Employer :
INVIVO-CRD PVT. LTD., is a global Clinical Research Organization established on 8th February 2008 at Ahmedabad, headed by Mr. Tejas Shah (M.S. Pharmacology London) appointed me as Clinical Research Associate on March 2008.
My Job description includes following roles & responsibilities :
1. Routinely serve as a Clinical Trial Leader for medium complexity studies (e.g. Simple mechanistic or simple first in man studies, complicated pharmacokinetic studies such as special populations /ADME).
2. May serve as study monitor for assigned studies.
3. Member of Early Clinical Development (ECD) sub-team.
4. Generate appropriate study-related documents.
5. Serve as the primary contact for site study manager and investigator at clinical site.
6. Set up and maintain the Trial Master File for assigned studies and SOPs.
7. Conduct, manage and document site training, pre-study, site initiation, monitoring and close-out visits according to Good Clinical Practice and processes (Essential documents collection, Informed consent process, Source data verification, Adverse Event and Serious Adverse Event reporting, drug accountability etc.)
Industrial Experiences :
Currently accomplished live Industrial training at Zydus Cadila HealthCare Limited located at Moriya, Taluka Sanand, Ahmedabad, Gujarat under Department of Clinical Research & Bioequivalence studies from April 2007.
My job profile consists of vivid knowledge in relation to BA/BE studies regulatory requirements in different nations [Japan, Europe, US, Canada, South Africa, Brazil & Australia]; Protocol review & validation; Study reports Review; Log [study reports, study CDs, Protocols, FDA & DCGI letters; Study products (API) –Complete accountability] maintenances; Monitoring & Auditing the conduct of BA/BE trials at site; Communication with different personnel’s in relation to query resolution; Filling of Pre-requisite forms; Protocol synopsis validation, F& D formulation validation with the samples, Timely packaging and sending of study samples at trial site with validated documents; etc.
Education :
Completed M.Sc.
in Clinical Research from Institute of Clinical Research (INDIA) [ICRI], Bangalore collaborated with Cranfield University, U.K. from September 2005 to March 2007. Rework on thesis under-process.
Completed M.Sc. in Biotechnology from People’s Education Society Institute of Applied Sciences (PESIT), Bangalore under Bangalore University in June 2005 with 69%
Completed B.Sc. in Biotechnology from N.V. Patel College of Applied Sciences (NVPAS), VallabhVidhyaNagar under Sardar Patel University, Anand in April 2003 with 68.4%
Completed XIIth standard from ASIA English High School, Ahmedabad under Gujarat Higher Secondary Board, Gujarat in March 2000 with 55%
Completed Xth standard Mount Carmel High School, Gandhidham under Gujarat Secondary Board, Gujarat in March 1998 with 76%
Relevant Skills :
Good basic knowledge of operating laboratory instruments like- PCR, Electrophoresis, centrifuge, laminar air flow (aseptic conditions), etc.
Understanding of regulatory affairs and functioning, governing the conduct of clinical trials in India, United States & United kingdom
Tissue culture and genetic engineering
Computer Skills :
Excellent knowledge in using Microsoft- Word, PowerPoint, Excel for report writing, presentations and data analysis
Operating systems : Windows XP, 2000, 98
Strengths :
Good orator, Negotiator, Independent, Determined, Patient listener, Excellent Team worker, Adaptable, Tech-savvy, Flare for scientific writing, Social & Religious.
Extra-curricular activities :
Participated in various district levels essay competitions and secured positions at various levels.
Science Exhibition Organizing and participation.
Participation in Nature’s Expedition organized by colleges.
Additional Experience :
Worked for 6 months as a Telemarketing Executive in a contract based company APT CONSULTANCY for TOYOTA where I under took inbound as well as out bound domestic calls and dealt with Offer promotions and Customer care and also worked for about 04 months as Voice based tele-executive Aditya Birla group’s BPO Transworks where I under took inbound as well as outbound International calls and dealt with Offer promotions and Customer care.
Languages known :English, Hindi & Gujarati
Date :
Place :