Clinical Research Associate

ASHISH WAGHAMARE

*** ********* ****

Edison, NJ *8837, USA

Ph.: 270-***-****

Email ID: **.***************@*****.***

OBJECTIVE

Seeking a position in Clinical Research associated with an emerging and globally focused organization with major emphasis on clinical trials where I will get opportunity to utilize my qualification and skills for the benefit of the organization.

SUMMARY OF QUALIFICATIONS

• Over 2 + years on-site clinical research monitoring experience

• Excellent knowledge of FDA regulations GCP/ ICH guidelines.

• Excellent writing and communication skills.

• Proficiency with MS office, Excel, Microsoft Word, Power point

• Extensive experience in data analysis using SPSS statistical software.

• Ability to manage multitasks at a given time.

• Ability to perform molecular and genetic analysis accurately.

• Maintain associated documentation, record keeping, collection, entry and organization of scientific data.

• Quick adaptability to the new systems.

EDUCATION

• Masters of Public Health (MPH); Western Kentucky University, KY, USA

• Bachelor of Dental Surgery (BDS); Yerala Medical Trust Dental College, Mumbai, India

CERTIFICATIONS

• Health and safety Instructor.

• Authorized Instructor in Lay respond, First aid and CPR/AED (Red Cross)

• Authorized Instructor in Basic HIV Education and Prevention (Red Cross)

WORK EXPERIENCE

Clinical Inquest Center, LTD, Ohio, USA July 2010-April 2011

Clinical Research Coordinator

Performed following duties:

• Monitoring assigned Clinical Research Trial.

• Implement and follow the protocol to meet both sponsor and investigators obligations.

• Identified potential investigators.

• Attended investigators meetings.

• Assisted in preparing reports on study population upon investigators request.

• Assisted in preparing Serious Adverse Events (SAE) report.

• Assisted in timely data collection, entry, interpretation and reporting.

• Resolution of data queries.

• Instructed the office staff to ensure compliance with FDA regulations and ICH guidelines.

Paragon Biomedical, Trivandrum, Kerala March 2007-July 2008

Clinical Research Associate

Performed following duties:

• Monitored Oncology clinical trials including quality assurance and subject safety.

• Analyzed and evaluated the clinical data including CRF to ensure site adherence to the trial protocol.

• Responsible to ensure adherence of the investigative site to the FDA regulations and GCP/ICH guidelines.

• Ensured the adverse events were reported accurately in timely manner.

• Verified the accuracy of data entered and reported by the staff.

• Managed all trip records, query resolutions and all expenses.

• Attended investigators meetings.

• Assisted in reporting Serious Adverse Events (SAE).

• Submitted feedbacks to the investigators, manager and sponsors.

REFERENCES: Will be provided upon request.

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