Clinical Research Management

PRASHANT SHASHIKANT PATEL

B. Sc(Chemistry), M.SC in Clinical Research, PGDCRM

Mobile: +91.94263 49547

E-Mail: ***************@*****.**

Snail mail: 80/b Neminath Krupa, Nr. U Ganda Park, Gurukul Road, Ahmedabad. 380052.

OBJECTIVE: Seeking an interview for a position where 2 year of clinical research operations and management experience will add value and bottom line results.

EMPLOYMENT SUMMARY: Employer's Name Job Title Period (form – to)

Life Care Institute of Medical Science & Research, Ahmedabad Senior Site Coordinator May 2010 till date

ACADEMICS:

1. Masters in Clinical Research from Cranfield University U.K affiliated to ICRI, Ahmedabad

2. Bachelor in Science (Chemistry) from Gujarat University

3. Post Graduation Diploma in Clinical Research Management from ICRI, Ahmedabad

THERAPEUTIC EXPOSURE:

Cardiology – DM ACS – Phase III – Global Trial – EDC (INFORM)

Cardiology – DM CHF – Phase III – Global Trial – EDC (ORACLE)

Cardiology - ACS - Phase III - Global Trial – EDC (INFORM)

DIABETES – DM ACS – Phase III – Global Trial – EDC (INFORM)

Cardiology – ACS - Phase IV - Global trial - Device trial

ROLES AND RESPONSIBILITIES ATTENDED:

Site Management:

• Prepare site for selection visit-site Initiation visit

• Attending Investigator’s Meetings & presenting site-specific data.

• Identification of potential subjects in consultation with the PI.

• Working knowledge of Interactive Voice Response System & Interactive web Response system for the randomization

• Schedule subject visits to ensure better subject compliance & subject retention.

• Preparation of doses according to protocol.

• Ensure that all information required by CRF is present in hospital source documents.

• Coordinate with different departments such as pathology, radiology, nursing staff, etc.

• Assist in archiving of study documents.

• Documentation of source notes & transcription of the data on CRFs (Paper & e-CRFs).

• Tracking study medication: receipt, storage, accountability & dispensing.

• Ensure the study is conducted in compliance with the Schedule Y, ICH-GCP, and Site and/or Sponsor’s standard working procedures under the supervision of the Principal Investigator.

• Report the AE, SAE to Sponsor, CRO and IRB/IEC within timeline

MAJOR

CERTIFICATIONS:

• Have completed Site specific GCP training on 30th Mar 2012 from Quintiles.

MAJOR TRAININGS, PROJECT & WORKSHOPS:

• Done a project on awareness of Tuberculosis in Ahmedabad, India as part of final examination.

• Research and Development in pharmaceutical industry of India and effect of new patent law.

• Have participated in different seminars & debates during the course

SOFT SKILLS:

Operating System : Windows XP, Remote dextop,

Packages : MS-Office Suite (Word, Excel, PowerPoint).

Internet & E-mailing : Advance Internet function usage, MS-Outlook.

CT Related System : EDC (InForm, RDC-ORACLE, Cenduit etc)

Others :Excellent Communication Skills and Negotiation Skills, Able to work under optimal situation, Established interpersonal and communication skills, Able to work effectively and efficiently in matrix environment

PERSONAL DETAILS:

Date of Birth : 02, Nov. 1983

Gender : Male

Marital Status : married

Nationality : Indian

Hobbies : Traveling, Reading, And Networking.

Languages known : English, Hindi, Gujarati

Personality : Optimistic, Cheerful, Goal-Oriented, Self-Motivated, Disciplined, Strong Stewardship abilities, Foresightedness, Dynamic.

REFERENCE: Dr. Sameer Dani, Director LIfecare Institute of Medical Sciences And Research .

MR. Naimesh Patel, Scientist-2, Lambda Therapeutics, Ahmedabad.

PRASHANT PATEL

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