Clinical research professional with pertinent experience in medical writing,clinical research site/project management and quality control of documentation.
Freelance Medical Writer (2008-2011)
- Full time
- Part time
- One time
March 2011 - March 2011
-Preparation of Safety narratives
-Preparation of Clinical Study Reports (CSRs), Annual Safety Reports (ASRs)
-Preparation of Protocol amendments, draft and review of IBs for submission to regulatory authorities and/or clinical teams
-Maintain records for all assigned projects including archiving
-Maintain the checklist for the documents prepared
-To deliver high quality documents, drafted as per pre-defined project/study standards and specifications, in expected turnaround time
-Participate in a wide range of support activities promoting the growth and development of medical writing team
-Also involved in preparation of in-house and project-specific SOPs.
Clinical Research Coordinator(In-house Monitor)
April 2010 - October 2010
December 2008 - May 2009
May 2008 - November 2008
Completed Project Thesis on "Perception of paramedical staff towards clinical research"
Clinical Research Associate(In-house and Field Monitor)
Clinsys Clinical Research
March 2007 - February 2008
Qualifications & Certifications