Medical writer, clinica scientist,QA,CRA

CURRICULUM VITAE

Dr. Shilpa Dipak Madavale

***,*** *****, *** *****, Celebrity paradise Doddathogur Electronic city

Bangalore - 560100 Mobile: +91-988*******

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

CAREER OBJECTIVE

 To learn and excel in the field of Clinical Research.

 To implement my excellent theoretical and practical knowledge into practice of clinical research for the benefit of organization.

 I wish to pursue a challenging career in Clinical Research Operations with enormous capabilities

CONCEPTUAL KNOWLEDGE:

 ICH –GCP Guidelines, Schedule Y

TECHNICAL SKILLS:

 Worked on Oracle Clinical and Remote data capture software’s

 Worked on Word, Excel and Power Point software’s

 Completed MS-CIT course in 2005

 Detailed knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements

 Basic Knowledge of clinical trial process.

QUALIFICATION:

 Pursuing Advanced PG Diploma in Clinical Research from LCRA, Bangalore

 Completed Bachelor of Ayurvedic Medicine and surgery from MUHS University secured 61.57% in year 2005.

 Completed HSC from Pune University secured 67.33% in year 2000.

 Completed SSC from Latur University secured 85.20% in year 1998.

PROJECT UNDERTAKEN:

1. Currently working as CRC in Lotus Clinical Research Academy, Bangalore

2. Worked as CRC for phase III trial study, BJMC Pune

3. Worked as duty doctor in City Hospital, Sholapur

PROFESSIONAL WORK EXPERIENCE:

Current Organization: Lotus Clinical Research Academy, Bangalore

Designation: Trainee CRC

Current Responsibilities: • Monitoring Visits for BA/BE study

• Conducting protocol, ICD, etc.. workshops

• Worked as Data Entry operator in Jakkur, Lotus Lab

• Preparing the presentations on various CR topics

Project: Phase III trial

Responsibilities: a) Administrative Activities

• Management of Ethics Review Board Submission

• Scheduling Protocol specific tests

• Scheduling patients clinical trial appointments

b) Clinical Activities

• Attending site training meeting

• Identifying potential eligible patients

• Assessment of inclusion/exclusion criteria

• Participation in obtaining informed consent form

c) Monitoring Activities

• Patient registration

• Recruitment follows up

• CRF completion, e CRF completion

• Collaborate with the clinical research associate

• SAE reporting

• Management ISF

• Maintaining drug accountability

Previous Organization: City Hospital, Solapur

Designation: Duty Doctor

Current Responsibilities: • Patient admission, diagnosis and observation

• Analysis of patients lab reports and discuss with senior doctors for treatment

AWARDS AND ACHIEVEMENTS:

 Got scholarship from 4th standard to 10th standard from SBI, Bank

 Got scholarship for 11th and 12th standard for getting highest score in Sanskrit

 Got scholarship for all 3 years of BAMS course from SBI, Bank

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