Clinical Research Coordinator : Resume CV

[amit shri 555]

AMIT SHRIVASTAVA
EMAIL - amit.shri555 AT gmail.com

Objective :
My career objective is to make a progressive career in clinical research

Experience :
Three Months work experience as a Clinical Research Coordinator in i5
Clinical Research Pvt. Ltd.

Awards and Academic achievements :
Attended ASSOCHAM’S conference on clinical trials ‘The Heart of Medical Science’ sponsored by ICRI on 4th Nov.2008
ICR (UK) certificate
SAS certificate

Education Credentials :
QUALIFICATION YEAR OF DIVISION BOARD/UNIVERSITY
PASSING :
Diploma in advanced 2009 2nd ICRI(Delhi) Clinical research
B.pharma 2008 1st RGPV University
12th 2002 1st M.P. Board
10th 2000 2nd M.P. Board

Computer Proficiency :
Basic : MS-word, MS-power-point, MS-excel
Networking : Basic internet knowledge

Skills in clinical research and clinical data management :
- clinical research knowledge
- Pharmacovigilance
- CRAs and CRCs working
- Basic clinical data management knowledge

Personal Details :
Nationality : Indian

DATE :
PLACE : Ahmedabad

[Guest]

Sandeep Mishra
E-mail :Sm821589 AT gmail.com, Sandy.mishra93 AT yahoo.com

Career Objective :
To achieve a challenging and creative position by using my interpersonal skills, analytical thinking, hard work and determination & to contribute in the growth of the organization.

Clinical research knowledge :
- Clinical Research fundamentals.
- ICH GCP, Indian GCP, ICMR Guidelines.
- Drug and Cosmetic act-Schedule Y, USFDA, European Union rules and regulations.
- Principles of Pharmacology & Drug Discovery & Development.
- Roles & Responsibilities of Key Stakeholder.
- Protocol development, Preparations & Planning for Clinical Trials.
- Essential Documentation filling & maintenance in Clinical Research & Regulatory Submissions.
- Clinical Trials Project Planning & Management.
- Monitoring essentials and checklists.
- Informed Consent process, enrollment, Case reports, Study reports, Source documents.
- Study Start up Process.
- Feasibility studies, Pre site visit, routine monitoring, adverse event reporting and Study close out.
- Drug & biological sample accountability, Coordination in investigational site
- Clinical Monitoring Essentials Compliance.
- IEC / IRB submission or notification procedure for approval of Study Procedure, Documents, Safety Reports / updates etc.

Professional Qualification :
Academic Credentials University Result :
PGDCRM & PV (Post Graduate Diploma in Clinical Research Management And Pharmacovigilance)-student Cliniminds, Delhi. Awaited
B. Pharma Rajeev Gandhi Technical University (RGTU) Aggregate
76.4%
HONOUR

Practical Hands-on :
- Presentation on 21 CFR 312
- Presentation on Patents and IPR
- Protocol designed for a multicentre, randomized, double blind, double dummy, parallel & comparative design phase III study.
- Informed Consent Document designed for the same study.

Technical Skills :
- MS Word,
- Excel
- Power point.
- Internet.

Strength :
- Self analytical understanding.
- Positive attitude in adverse situations.
- High degree of self thrust and motivation.
- Confident, strong will and easily adaptable to any environment
- Innovative thinking.

[Guest]

Divyang Gautambhai Dalvadi

Hobbies :Music,Reading,Traveling,Playing,

Educational Qualification :
Degree Board/University Passing Year Percentage:
September 2005
September 2006
University August 2008 67.10%
Bachelor in Pharmacy,(3rd Year) Rajiv Gandhi University August 2009 66.00%
Bachelor in Pharmacy,(Final Year) Rajiv Gandhi University August 2010 64.14%
Average Percentage 66.00%