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To,
The Manager,
Human Resource Development,
Subject: - Application for a suitable position at your esteemed organization.
Respected sir/Madam,
I. Mr. Syed Ameer Basha. Would like to forward my candidature for the suitable post in your
esteemed organization, please find my CV annexed herewith for your kind perusal.
As is B.PHARM s, 5 years11 months of Experience in Clinical research, as Senior Clinical
Research Associate. I assure you that I will prove my efficiency to the appreciable level up to the
satisfaction of my superiors and for betterment to the organization.
With due respect I wish to state that I am interested to serve for your organization by faithfully
rendering services with utmost sincerity and dedication in order to expand horizons of my
knowledge and therefore I humbly request your kind consideration regarding suitable post in
your esteemed organization.
Anticipating your positive reply as and when there is opening suitable for my profile. Kindly
oblige and consider my application favorably.
Thanking you,
Yours Sincerely,
Syed Ameer basha,
Mobile. No : +91 9160351256,
E-mail:Syedameerbashabasha@rocketmail.com,
Syedameer 891@ gmail.com.
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CURRICULUM VITAE
SYED AMEERBASHA
EMAIL: Syedameer 891@ gmail.com.
: Syedameerbashabasha@rocketmail.com.
Mobile No: 9160351256
CAREER OBJECTIVE:
To establish myself as professional in an esteemed organization with commitment and adding
value to the organization I work for, that gives me scope to apply my knowledge and skills and
to be a member of a team , that dynamically works towards success and growth of the
organization.
PROFESIONAL EXPERIENCE:
Currently working as Senior Clinical Research Associate from 15 September 2014 to till
date in the Department of Clinical Pharmacology, RA Chem Pharma Limited, CRBIO
Division, Balanagar, Hyderabad.
Worked as a Clinical Research Associate from 30 August 2010 to 05 Sep 2014 in the
Department of Clinical Pharmacology, Aizant Drug Research Solutions Private Limited,
Hyderabad.
JOB RESPONSIBILITIES AS SENIOR CLINICAL RESEARCH ASSOCIATE
Ensuring the conduct of clinical trials as per ICH Good Clinical Practice and Study
Protocol.
Delegate duties to CRA - custodian as per the study requirement.
Checking of study requirements before starting the study.
Co-ordination with all concerned departments for proper planning & execution of studies.
Recording the AEs and SAEs along with their causality assessment among study
participants.
Monitoring the study activities throughout its duration, and ensuring their documentation.
Verifying that data entered on to the CRFs is in line with source data/document, and
recommending the corrective actions as and when required.
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Ensuring the filing and maintenance of the required regulatory documents.
Designing data collection forms, such as case record (report) forms (CRFs).
To carry out checks of various phases of studies as per SOPs and Protocols and report to
Unit head.
Verification of study file, essential documents, clinical updates, raw data and study report
for data accuracy.
Preparation and Review of SOPs according to the Regulatory requirements.
Coordinating preparation of clinical study updates.
Co-ordination with the Principal Investigator for compliance with sponsor requirements
and timelines.
Communication of Study Updates with Investigators, Sponsor and Project management.
Query resolution management of the audits related to clinical aspects and other issues in
coordination with quality assurance department.
Responsible for communication of deviations with respect to the protocol, SOPs, GCP
and the applicable regulatory requirements to the investigator for taking corrective and
preventive actions.
Co-ordination with Monitors during conduction of Studies.
Submission of Study related documents to Monitor for verifying the documents.
Preparation of audit report responses to Monitor.
Carry out Periodic in process and retrospective audits of various phases of BA/BE studies
as per SOPs, Protocols and report to the Manager.
JOB RESPONSIBILITIES AS CLINICAL RESEARCH ASSOCIATE
Reporting of Volunteers and their admission into clinic.
Obtaining the informed consent from the study subject.
Check-in and Check-out of the subjects.
Performing the Custodian activity.
Administration of study drug to the subjects.
Done dispensing supervision for various types of projects like (Suspension, Apple sauce
etc.)
Performing any other activities as directed by the Principal Investigator
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Compilation of Study file, Essential documents, Clinical updates, Trial Master File, Raw
data and safety data regarding AE`s for data accuracy.
Responsible for verification of Study related documents for archival
Review of Clinical Calibration documents, raw data and study reports, as per SOP`s and
regulatory requirements.
Reviewing of Protocols, CRF`s , ICD`s based on applicable regulatory requirements and
SOP`s.
.
PROFESSINOAL QUALIFIACTIONS:
B.Pharmacy from Nimra College of Pharmacy, Jupudi, Krishna district, AP. 2007-
2010.
Diploma in Pharmacy from Nirmala College of Pharmacy, Mangalgiri, Guntur, AP.
2005-2007.
Intermediate from Hindu College, Guntur, AP.
SSC from Jawahar English Medium Public School, Guntur, AP.
AREA OF INTEREST:
Clinical Trials.
Bioavailability and Bioequivalence studies.
Pharmacovigliance.
In site monitoring activities and out site monitoring activities.
IMPLANT TRAINING:
Undergone 3 months hospital training in Government Hospital, Guntur, AP.
COMPUTERSKILLS:
MS Office (Word, PowerPoint, Excel).
M.S. Outlook.
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SKILLS:
Team player with outstanding negotiation and organizational skills.
Prone to adopt leader ship qualities to carry work forward at all times.
Client focused approach to work.
A flexible attitude with respect to work assignments, new learning.
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload
with attention to detail.
Able to take initiative and work independently.
Sense of urgency in completing assigned tasks.
Detailed knowledge of GCP and ICH guidelines including basic understanding of
regulatory requirements.
Knowledge indifferent regulatory guidelines like ICH (GCP), USFDA, ANVISA, DCGI,
and EMEA.
Review Protocol, ICF and Case Report form.
Delivering and implementing the Projects as per Scheduled deadlines extending past
implementation and maintenance support to the technical support team and Client.
Certifications:
Underwent `GLP (Good Laboratory practice) training at Aizant drug research solutions,
Hyderabad, India on 2nd Nov 2011.
Underwent `ICH (Good Clinical Practice) training at Aizant drug research solutions,
Hyderabad, India on 21st Feb 2013.
Underwent `ICH (Good Clinical Practice) training at RA Chem Pharma Limited, CRBIO
Division, Balanagar, and Hyderabad on 23 Oct 2014.
PROJCET WORK:
Enhancement of solubility of Naproxen sodium by solid dispersion techniques.
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PERSONAL PROFILE
Date of Birth : 10-08-1988
Father’s Name : Syed Kareem
Marital Status : Married
Nationality : Indian
Religion : Muslim
Languages known : Telugu, English, Hindi
Permanent Address : Syed Ameerbasha
S/O Syed Kareem
D.NO:15-6-52
Redla Bazaar, Old Guntur,
Guntur – 522001.
Declaration:
I hereby declare that the above –mentioned information is true to the best of my knowledge and
abilities.
Date:
Place:
(Syed Ameer basha )