RESUME
Address:
Dr. Nurul Hassan.Shaik,
Kodi Chikkanahalli,
Bangalore-560076,
India.
Mobile : +91-890*******
E-mail: *********@*****.**.**
Objective:
To work in an Organization which provides me with a productive environment so that it can help in improving skills and updating my knowledge at the same time providing my best for the betterment and programs of the organization
Educational Qualification:
Degree
College
University Bachelor of Dental Surgery (BDS) in 2003
Maruthi Dental College, Bangalore
Bangalore University, Bangalore
Additional Qualification:
P.G.Diploma:“Clinical Trial Management & Regulatory Affairs”(November2006) In Vaatsalya Healthcare Solutions Pvt. Ltd., Bangalore.
E-Learning Courses:
1
2
3
4
5
6
“Process for approving Generic Drugs” (July 2006) Food and Drug Administration - Centre for Drug Evaluation and
Research
“Drug Development and Related Activities in the United States” (July 2006) Food and Drug Administration Centre
for Drug Evaluation and Research
“Incorporating Cancer Clinical Trials into Your Practice, Section I” (July 2006) National Institutes of Health (NIH)
“Incorporating Cancer Clinical Trials into Your Practice, Section II” (August 2006) National Institutes of Health (NIH)
“Human Participants Protection Education for Research Teams” National Institutes of Health (NIH)
“NIH Clinical Research Training course”, & Certification of Completion –Number: 614556
Total Experience: 5+ years in clinical research:
1
Present working as Senior Clinical Research Coordinator In Kidwai Memorial InstituteOfOncology,Banaglore,India.
2
Previously Worked as a Clinical Research Coordinator in King Faisal Specialist Hospital & Research Centre, Riyadh, Kingdom Of Saudi Arabia, from Feb2010 to Agu2011.
3
Previous worked as a Senior Clinical Research Coordinator. In Apollo Hospitals, from June 2008 to Dec 2009
Bangalore through AHERF. India.
4
Previous worked as a Clinical Research Coordinator. In Kidwai Memorial Institute of Oncology Bangalore, India. From 2006 Sept to June7th2008.
EXPERIENCE IN CLINICAL RESEARCH: Hands on Experience In Clinical Trials:
1 A randomized,Double-Blind,Placebo-Controlled,Phase-2B Study to Assess the Safety and Efficacy Effects Of A-34 on Subjects with Sepsis and Disseminated Intravascular Coagulation.
2
International, Multi centre, randomized, double blind study to compare the Overall mortality in acutely ill
medical patients with X Versus placebo in Addition to GYS.
3 A Phase-II safety Efficacy Study of BTM +Pac &Cab Patients With Previously Untreated Locally Advanced or
Metastatic NSCLC.
4
A Multicentre Open Label Phase III-Study to Evaluate the safety and Efficacy of XY(AB) In Patients with
Relapsed or Refractory Low-grade or Follicular Non Hodgkin’s lymphoma.
5
Randomized, Open –label, Multicenter, Phase-3 Study of XYZ Standard Supportive care verses Standard
Supportive care in Anaemic patient Metastatic breast cancer.
6
A Randomized Double-bind Multicentre Study of AB compared with CD in the treatment of Bone Metastases in Subject with advanced Breast cancer.
7
A Pivotal Phase-3 Observer-Blind A Randomized Clinical trial of the Efficacy and Safety of HIJ compared to
YZ for the Prevention of ACUTE –ONSET & DELAYED ONSET chemotherapy Induced Nausea ,Vomiting
following Administration of Moderately or highly Emotogenic Chemotherapy.
8
A-Phase-3, Multicenter, Randomized, Placebo- controlled, Double- blind trial of in Combination with XY
And AB for Advanced Non -small cell lung cancer.
Responsibilities Delegated :
1 CRF/EDC completion, Timely resolved DCF’s.
2
Performed data entry into OC-RDC within timeline Specified by Sponsor (within 48 hours of subject Follow up Visit).
3 Screening, recruiting of patients based on eligibility criteria.
4 Scheduling of visits and follow-up of qualified patients.
5 Responsible for all associated EC work.
6 Coordinate site recruitment, initiation, protocol development and Implementation.
7 Develop and maintain project quality assurance and finalize project Data.
8 Produce and maintain projects budget.
9
Assists with archiving study documents for completed clinical trials Coordinates subject enrolment tracking system and prepare reports for project team Involving and Coordinating site management aspects in clinical trials.
10
Maintain Source Documents and Laboratory Investigations, submitting AE and SAEs to Sponsor & EC and
other applicable regulatory requirements within the time lines
11 Coordinating all activities related to shipping samples to centre labs.
12 Maintaining Investigator Site File.
13 Coordinating Site initiation visits, routine monitoring visits, closeout Visits.
14 Resolving Data Queries.
Working Knowledge in Clinical Software’s:(X-TILE, JMP& SPSS) :Tissue Bank
1 Preparing Proformas for Clinical Data Abstraction
2 Clinical Data Abstraction from patient files.
3 Entering Clinical Data (Variables) in excel sheets.
4 Analysis the data using Marker in X-TILE clinical software
5 Taking cut points from X-TILE (population sets)
6 Using SAS JMP software for analyzing the data variables selecting the Marker
7 Using SP SS for Analysis, Graphs & Box-plots as well as JMP
8 Searching &Reviewing articles from Medical journals for Publication purpose
9
Using Freezer Software for Samples store, allocations and maintaining the data for analysis purpose.
Personal Details:
Current Location:
Date of Birth:
Fathers Name:
Nationality:
Sex:
Marital Status:
Passport No:
Bangalore
07/06/1972
Shaik. Dada Saheb
Indian
Male
Married
H5170137
I hereby declare that all information that I enclosed here is true and brief as per my knowledge and belief.
Place: Bangalore
Date: 18/04/2012
(Dr NurulHassan.Shaik)