Resume

Quality Assurance Clinical Research

Location:

Posted:

February 15, 2013

Dr Hemavathi Narayan

abodmu@r.postjobfree.com

Highly talented and accomplished Clinical Research personal with extensive

skills and experience

SUMMARY OF QUALIFICATIONS

Over 2 years of experience in Clinical Research . Proven ability to manage

multiple studies simultaneously, from inception to completion. Superior

writing skills, able to prepare proposals, consent forms, reports,

submissions, and public relations articles. Thorough understanding of

hospital Internal Review Board regulations. Adept at maintaining compliance

with hospital and federal standards. Ability to liaison with surgical

staff, as well as with representatives from pharmaceutical companies and

academic institutions. Excellent communication and organizational skills.

PROFESSIONAL BACKGROUND

Clinical Research medical writer

LOTUS Labs Pvt Ltd, Bangalore

Coordinate clinical trials for major pharmaceutical companies,

Communicate closely with representatives from Actavis, Pfizer, Novartis,

and other research partners

Author informed patient consent forms for clinical trials, in accordance

with Internal Review Board (IRB) standards.

Collect data from patient examinations, prepare medical records for

sponsor's clinical report forms.

Preparing draft protocols by reviewing the literature discussing with

Pharmacokinetic department, Analytical department, Principal Investigator,

Clinical Investigator, Co-Investigator, Medical Advisor and Clinical

Quality Affairs department.

Conducting the Protocol Review meet (PRM).

Clinical research quality Assurance

LOTUS Labs Pvt Ltd, Bangalore

Manage multiple studies simultaneously, Coordinate studies from inception

to completion.

Monitor studies to ensure continued compliance with federal, IRB.

Monitoring the Interview and recruitments of the subjects for studies,

following protocols established jointly by surgical staff and project