Quality Assurance Clinical Research

Akruti Desai

Certified Clinical Research Associate

********@*****.**.**

OBJECTIVE: To obtain position as Clinical Research Associate

Summary of Qualifications

• Over a year of on-going Clinical Research Monitoring Experience

• Excellent knowledge of ICH, GCP, FDA, TPA and EMEA Regulations

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

• Excellent written and verbal communication skills

• Ability to multi-task with strong organizational skills

• Experience with medical techniques such as phlebotomy, hematology, biochemistry, microbiology, serology and clinical pathology.

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

Education

• Clinical Research Training through NIH

• Clinical Research Professional Development Program Kriger Research Center, Toronto, Ontario

• Clinical Research Associate training from Veritas Healthcare Solutions.

• MBA in Clinical Research, Tilak Maharashtra Vidyapeeth University, India

• Bachelor of Science, Life Science, Mumbai University, India

• Diploma in Medical Technology, SNDT University, India

Work Experience

Clinproxy Research Services Oct 2010 – Oct 2011

Regional Clinical Research Associate ( Home Based Intern)

Phase II Study Efficacy of lowering effect of PROLIPOSTAT on Blood concentrations of low-density lipoprotein cholesterol (LDL-C) in patients with normal and elevated blood concentrations of LDL-C in patients with normal and elevated blood concentrations of LDL-C. Randomized, Double-Blind, Placebo Control.

Performed the following duties in the above project:

• Member of clinical development team.

• Identified potential investigators.

• Designed CRFs and sent draft CRFs for review

• Planned investigators meetings.

• Prepared randomization list.

• Participated in development of informed consent forms and prepared letters of agreement/contracts.

• Created checklists for initiation visits, periodic visits and close up visits.

• Performed drug accountability and reconciled counts with CRF, source data and dispensing logs.

• Prepared final study reports.

TATA Hospital, India (Oncology Studies) (January 2008 – April 2010)

Performed following duties:

• Participated in initial and on-going protocol and CRF training.

• Served as the primary contact for the clinical sites/Sponsor.

• Participated in the generation of study specific monitoring plans.

• Assisted in the development of protocols and Case Report Forms.

• Participated in Sponsor and Investigator/Initiation Meetings.

• Participated in the study development and start up process including reviewing protocols, designing and/or reviewing CRFs preparing informed consent forms, developing study documents, organizing and presenting at investigator meetings and working with management on monitoring strategy.

KEM Hospital, India (Diabetes Studies) (December 2006 – December 2007)

Performed following duties:

• Designing data collection forms known as case record forms.

• Coordinating with the ethics committee which safeguards the rights, safety and well- being of all trial subjects.

• Locating and assessing the suitability of facilities at a study center.

• Monitoring trial throughout its duration, which involves visiting the study centers on a regular basis.

• Verifying the data entered in the CRFs is consistent with patient clinical notes, known as source data/document verification.

• Writing visit reports.

• Filing and collecting trial documents and reports.

Reliance Life Care, India (February 2006 – November 2006)

Performed following duties:

• Data management.

• Calibrate and maintain equipment.

• Comply with quality assurance procedures.

• Conduct pathologic tests.

• Prepare patients for examination.

P H Medical Centre, India (May 2004 – January 2006)

Medical Technologists

Performed the following duties in following departments:

• Biochemistry – Performed blood test for Lipid Profile, Kidney Function Test, Liver Function Tests, etc

• Hematology – Performed blood test for Complete Blood Count (CBC), Prothrombin Test, Blood Group, etc

• Microbiology – Growing of microbes on agar plates

• Serology – Performing test like HIV, HbsAg, HCV, Widal, RA, CRP

• Clinical Pathology – Urine Test, Urine Pregnancy Test, Stool Test, Semen Analysis, etc.

Contact this candidate