BSc+PG Diploma in Clinical Reserach with 8 months exp as CRC Resumes in India: Arati

BSc+PG Diploma in Clinical Reserach with 8 months exp as CRC Resume

Contact Candidate

Name:

Arati

Location:

India

Experience:

Willing to Relocate:

Willing to Travel:

Most Recent Job Title:

BSc+PG Diploma in Clinical Reserach with 8 months exp as CRC

Personal Website:

Objective:

Seeking a challenging career in Clinical Research, using my knowledge and experience gathered along with the latest technologies & practical work available for Research in the Clinical Research area.

Resume Text:

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ATION

Degree / Certificate University / Board Description Class
B.Sc. Mumbai University March 2005 54.25 %
H.S.C. Mumbai University April 2002 75.50 %
S.S.C Mumbai University March 2000 76.52 %

Additional Qualification

 Completed Post Graduate Diploma in Clinico Regulatory and Patent from Ruia College of Science in July’2007.

Topics covered under Clinical Research Course:

• ICH-GCP Guidelines
• Phase I, II, III IV Protocol
• Activities of a Clinical Trial
• Sponsor, Investigator and Project Manager roles and responsibility as per ICH-GCP
• Ethics committee
• Selection of a CRO: Why & How?
• Auditing in Clinical Trial
• Clinical Trial Monitoring
• Safety reporting in Clinical Research
• Bioequivalence
• Essential Documents
• Informed Consent and Protocol
• Amended Scheduled Y
• Feasibility survey
• Regulatory and Patent

PROFESSIONAL EXPERIENCE

1. PIRAMAL LIFE SCIENCE

• Working as Clinical Research coordinator (CRC) from Oct’2007 on KEM Hospital Site

Randomized, Double Blind, Placebo controlled, Pilot studt to evaluate the safety and Efficacy of the New Investigational Drug in Subject with Moderate to Sever Psoriasis.

Responsibilities :

Administrative :

• Maintain Site Master File.
• Assure all study documentation is maintained
• Interact with IRB, lab staff, clinic staff, other departments in institution
• Interact with Principal Investigator and Sub investigators.
• Interact with Sponsor.
• Coordinate and participate in monitoring visits with sponsor.
• Facilitate inspections/audits
• Electronic Data capturing
• Reporting SAE to Ethics committee and Sponsor in specific timeline

Responsibilities Involving Subjects :

• Recruit study subjects.
• Assess subjects for eligibility.
• Discuss study with subject and assist in obtaining informed consent.
• Schedule subject assessments/visits.
• Assure all study tests and visits are done at appropriate time intervals.
• Evaluate study subjects at appropriate intervals.
• Assess laboratory data and clinical signs for potential adverse events.
• Provide information for treatments and reactions.
• Administer or dispense investigational agent as needed under investigator's supervision.
• Promote subject compliance by providing patient support and education.
• Arrange for study subject compensation.
• Comply with FDA regulations for conducting clinical trials.
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2. JOHNSON & JOHNSON CO. LTD. Lifescan Division

• Worked as Customer Care representative from Sep’ 2005 to Feb’2007.

Responsibilities :

• Complaint Handling
• Phone system management
• Customer data base and Customer retention Program
• Local Communication
• Logistic and mailing

3. HAFFKIN’S INSTITUTE

Attended training at Haffkin's Institute in May 2004

Topics covered under training ELISA, RIA Western Blot, animal tissue Culture, etc.

PERSONAL DETAILS:

• Name : Arati R. Desai

• Date of Birth : 8th December 1984

• Age : 24 years

• Sex : Female.

• Nationality/Religion : Indian/Hindu.

• Marital Status : Unmarried.

• Languages Known : Marathi, Hindi, and English (Speak, Read and Write)

Place :
Date : (Arati R. Desai)

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