Job Objective :
Seeking for the position of Clinical Research Associate in the medical field while merging into a globally focused or organization that will purposefully utilize my qualification while offering several opportunities to integrate personal enrichment with professional goals..
Work Assignments :
** ICON-ARO, Mumbai. Designation: Clinical Research Associate - May 2010 to still working
Job Responsibilities:
** Ensuring the implementation of project plans as assigned.
** Responsible for site monitoring, site management, site administration & registry management for clinical studies according to CGP, ICH Guideline and Standard Operating Procedures.
** Acted as Lead CRA or Local Coordinator in project as assigned.
Trial Participated in :
Indication of Trial Clinical Phase of Trial (I-IV)
Locally Advanced Head and Neck Cancer IIb
Non-Myeloid Malignancies III
Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers. III
Metastatic breast cancer III
Chronic myeloid leukemia
** With the T315I BCR-ABL Gene Mutation. II
Chronic myeloid leukemia
** Who Have Failed or Are Intolerant to XXX Therapy. II
Professional Synopsis :
** Well acquainted with ICH GCP, Schedule-Y, Pharmacovigilance, CIOMS, ICMR Guideline
** Over 2 years of experience in Medical Practice & Consultation and Hospital Administration.
** Possess strong oral and written communication skills, analytical ability, a good team player and capability to perform under stress and strenuous conditions.
** Understanding of global regulatory requirements
Academic Credentials :
** Post Graduate Master in Pharmaceutical Medicine (Clinical Research) from IDD, G.S.Medical College & K.E.M Hospital- Mumbai, in November 2010, (Full Time) Pass Class - First Class
** M.B.A.
in Clinical Research from Ruiea College. Matunga, Dadar (E)( Tilak Maharashtra University- Pune) in 2010, (Distance) Pass Class - First Class
** Bachelor of Homoeopathic Medicine & Surgery from Smt. K. B. Abad Homoeopathic Medical college, Chandwad , Nashik in 2007. Pass Class– Second Class
Professional Registration:
Registered Medical Practioner, Registration No: 45397
Training Programs Attended :
** Software validation & data Management in field of Clinical Trial Organized by Doctus System, at Hotel Taj Land End, Bandra West, Mumbai. Dated 28- 29 December 2010.
** Good Clinical Practice & Research Methodology. Organized by Maharashtra University of Health Science, UDIRT Department. Nashik. Dated: 17- 18 January 2010.
** Prescription monitoring of “Acute ( Monsoon related ) Febrile Illness in Adults” by Infectious Disease Department Seth G.S.Medical College & K.E.M. Hospital, Mumbai.
** Pharmacovigilance Activity (ADR Monitoring, Reporting & Causality analysis) in Surgery Dept., KEM Hospital, Mumbai.
** MS-CIT, Nashik in Mar’09 Scored : 70 %
Co- Curricular activities & achievements:
Conferences Attended:
** Conference attended on Oncologycal Trial & It’s Trend in India , At Hotel Grand Hyatt, Delhi. Dated : 11 – 14 March 2011.
** Software validation & data Management Organized by Doctus System, at Hotel Taj Land End, Bandra West, Mumbai. Dated 28- 29 December 2010.
** Participated in 3rd International Annual Conference on
M.B.A. Project:
Presented project on Clinical Research Organization (Overview) during course curriculum of M.B.A. in Clinical Research
Presented Protocol, ICF, CRF and IB on Intravenous DEVCAHS14900 (Desvenlafaxine) in
Depression for summer training project for the duration of May- December 2009 (Mock Protocol)
Computer Skills :
** MS Windows XP OS , MS Office , Internet, Outlook, MSCIT