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Research Analyst Resume

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Morris Plains, NJ

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Skills

  • Creative problem solver
  • Excellent communicator, team player
  • Good organization skills

Computer skills
MS Office (Word, Excel, PowerPoint)

Education/ Certification/ Training

Diploma in Clinical Research Professional Development Program
Kriger Research Center

  • ICH GCP Training
  • Clinical Site Monitoring (site selection, initiation, monitoring and close out)
  • Adverse Event Reporting
  • Pharmacology and Medical Terminology for Clinical Research Professionals

Master of Surgery ENT (Otolaryngology): MD, DORL, FCPS
M.B.B.S (Bachelor of Medicine and Bachelor of Surgery)

Clinical Research Experience

Confidential
Research Analyst Current

Responsible for creating and entering Clinical records and events into the Trackwise database. This includes data entry, scanning documents, reviewing and analyzing documents and closing records in the database.

  • Data entry
  • Scanning documents
  • Reviewing documents for accuracy
  • Close-out of training records/Updating training records

Confidential
Research Assistant Jun - Jul 2010

  • Researched and reviewed data of Investigator and Investigator sites
  • Prepared clinical trial study specific listings and solved queries
  • Researched medical and scientific topics utilizing various information services including in-house reference system, on-line journal subscriptions, libraries,
    and literature search databases (i.e. Pub Med, Med Line)
  • Proactively highlighted slippages and deviations
  • Entered Clinical trial data into database
  • Worked towards meeting study milestones
  • Collected and kept records of clinical trial study information of investigators, thisincluded publications, scientific and medical data research, and clinical
    studies
  • Filing of relevant documentation for follow up review

Confidential
Trainee Clinical Research Associate Nov 2009 - Jan 2010

Phase I Study of the safety and Dose determination of Immuno-Stimulatory
Therapy Agent for Bladder cancer, melanoma and colon cancer

  • Phase II Study of the Efficacy of the healing effect of recombinant human epidermal growth factor on diabetic foot ulcers
  • Project: Proper use and cost reduction strategy for Prescription and Non-prescription drugs, Phase 4 Clinical Trial Post Market Surveillance

Training Responsibilities included:

  • Member of clinical development team
  • Managed assigned investigational study sites and performed on site quality review's of case report form data
  • Verified case report form information against source documents and reconciled data entry queries, adverse event reporting
  • Designing CRF's, sending draft CRF's for review
  • Developed and implemented site initiation, routine monitoring, and closure checklists

Confidential
Senior Resident 1998-2001
Clinical study of "Management of acute Vertigo with Betahistine"

Responsibilities:

  • Patient screening and recruitment
  • Drug dispensing and drug accountability
  • Patient monitoring and follow up
  • Evaluated the parameters of frequency, duration and severity of vertigo attacks for recording in CRF's
  • Prepared periodic reports and compiled clinical data as requested by the sponsor
  • Maintained a balanced overview of safety and efficacy information for assigned investigational products
  • Confirmed classification of seriousness of vertigo as appropriate
  • Worked with the clinical team for the successful completion of the trial

Medical/Physician Experience

Department of Otolaryngology

Confidential,2002
Confidential, 2001
Confidential, 1998 -2001

Publications

Management of acute vertigo with Betahistine

Indian journal of Otolaryngology and Head and Neck Surgery Vol 52 #2,
April-June 2002 (pgs151-158)

  • This open, prospective clinical trial study was carried out in 29 outpatients of vertigo with Betahistine treatment at a dose of 16 mg three times daily far a
    maximum treatment period of 6 weeks or earlier until remission of vertigo
    attacks
    Confidential

Fungal Sinusitis - The new epidemic

Bombay Hospital Journal, Vol 43 #3, 2001 (pages 343-347)
Confidential

Intratemporaldermoid

Bombay Hospital Journal, Vol 43 #3, 2001 (pages 422-424)
Confidential

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