www.asiaticlinical.com Asiatic Clinical Research Pvt Ltd Bangalore : Clinical Research Associate

[muthukalee]

asiaticlinical.com

Clinical Research Associates
* Opening for experienced clinical research associates.
* 1-2 years experience in oncology trials is a must
* Pleasant personality with good communication skills.

About us:
Asiatic Clinical Research is a full service contract research organization with a focus on phase II - IV trials. We work as a partner with the Pharmaceutical and Biotechnology companies to conduct the study ethically and achieve the end point.

INDIA - Gives us the edge

[LIST][*]Large genetically, culturally and socio-economically diverse patient pool.[*] Huge treatment naive patient population.[*] Wide variety of diseases ranging from infectious diseases to degenerative diseases.[*] High Doctor: Patient ratio.[/LIST]
Contact us:
Asiatic Clinical Research Pvt. Ltd.
169/53, 14th Main Road,
1st Block East, Jayanagar,
Bangalore 560 011

http://www.asiaticlinical.com/careers.htm
http://www.asiaticlinical.com/

[Guest]

I am vimala, M.Pharm graduate and i have 1.3 yr experience in Clinical Research as CRC, i know the exact duties of CRA because during my work i met and worked under for about 5-6 CRAs. I worked in 4 different trials of different phases like 2,3 for 4 different indications like AF, Diabetic foot ulcer, CKD, Diabetes with Cardiac complications. I am capable of handling 4-5 different projects at a time. So i would request you to consider my CV for this job.Please contact me over 09989317234 or to this mail id.

While working, I have got hands on experience in:
Ø Assisting in Informed consent procedure
Ø Randomization procedures
Ø Using IVRS/IWRS
Ø Investigational Drugs handling, storage, dispensing
Ø Collection, processing and shipment of biological samples to Central labs
Ø Data management
Ø Writing and maintaining source documents of subjects.
Ø Checking Drug Compliance
Ø Completing eCRFs
Ø Resolving DCFs
Ø Maintaining IMP accountability and Temperature logs at site
Ø Reporting SAE/AE/Events to CRO and EC
Ø Coordinate all subject related appointments and investigations

Well versed with ICH-GCP guidelines and underwent training and received certificate for the same.

So once again i would request you to consider me for this job.

Thanking you,

Warm regards,
Vimalacharitha.L,
vimala.pharma@gmail.com

[Guest]

Career Objective
To associate with an organization which progresses dynamically and gives me a chance to update my knowledge and enhance my skills in the state-of-art technologies and be a part of the team that excels in work towards the growth of the organization and gives me satisfaction thereof.
Professional Summary
Having 5 years 10 months of experience on Drug Discovery and Bioinformatics with GVK BIO.
- Experience on quality Analysis of the databases
- Best practice on maintaining the quality databases using softwares like ACD, Chem Office, Scifinder, ISIS Draw & Base, Pubmed etc.
- Experience on identifying and designing of chemical structures
- Good collection of Biological, Chemical and Pharmacological information of the compounds
- Experienced on developing different forms for databases covering Binding, Chemical, Functional, Biological activities, Toxic information and Pharmacological information from journals and patents, which include
o Cas database like Cas Reaction Narratives, Pepsi-lite
o Biomarker database
o Target inhibitor database like Kinases, Phosphatases, Proteases, GPCRs, NHRs, Transporters, Ion-Channel blockers.
o Drug database
Professional Experience
- Working as Research Associate with GVK BIO Informatics division, Hyderabad, from July 2009 to till date
- Worked as Junior Research Associate with GVK BIO Informatics division, Hyderabad, from June 2006 to July 2009.
- Worked as Project Trainee with GVK BIO Informatics division, Hyderabad, from August 2005 to June 2006.
Education
- PG Diploma in Protein Modeling and Rational Drug Designing during the year 2005 from GVK BIO
- Master of Sciences from “Nagarjuna University”, Guntur during 2004 with 71%
- Bachelor of Sciences from “Nagarjuna University” during 2002 with 73%
- Board of Intermediate Education during the year 1999 with 65%
- Board of Secondary Education during the year 1997 with 70%
Certifications
Protein Modeling and Relational Drug Designing certification from Accelerys Software
Soft Skills & Tools
- Accelrys (Insight II, Catalyst, Cerius2) ISIS/Desktop, MS Office tools
- Windows (95, 2000/2003, XP, Vista), Unix, Linux
- Databases : ISIS/Base (a relational database)
- SAS, C
Insilico Skills
- Development of 2D & 3D databases, DNA and Protein sequence Analysis, Protein Structure Analysis, Homology Modeling and Visualization Tools
- Pharmacophore generation, QSAR studies and Dynamic studies of various inhibitors
- Sequence and Structure Databases, Sequence Alignment tools
- Structure based Drug Design and Analogue based Drug Design
- Drug Design based on Pharmacophore Analysis
Projects Handled/Involved
Project #1 :
Project : CAS-Reaction Narratives
Duration : Nov 2009 to till date
Client : CAS
Software : CAS Tool (Chemical Abstract Service Tool), Ms Word
Team size : 30
Description :
Capturing the experimental procedure and spectral information for a product from scientific articles which is uploaded into SciFinder using Ms Word and CAS Tool. This tool is designed by GVK BIO which is used to maintain the quality and quantity of data. Updating the data (Product, Reactant, Reagent, Catalyst and Reaction condition information) from scientific articles.
Role :
- Curating the chemical reaction narratives from different journals and patents
- Quality Analyst which includes maintaining the quality of the reaction records information through review.
Project #2 :
Project : Pepsi-Lite
Duration : Jan 2009 to Nov 2009
Client : CAS
Software : ISIS-Draw, ISIS-Base, Chem-Draw
Team size : 10
Description :
Pepsi-Lite is a custom curation project where we select chemical substances that are explicitly named in example section of patents. CAS has framed some rules to identify, select and record these eligible substances from the example section of the patent. CAS has also given certain situations/criteria for recording substances and for NOT recording substances. The eligible substance must be recorded with its respective page number, page label, and example number according to the xml schema. In addition to recording the eligible substance names, GVKBIO will generate a Molfile for each selected substance. In addition to named substances, GVKBIO will also select eligible structures and generate a Molfile for each. Source documents will typically consist of scanned TIFF pages for the Patent to be processed by GVKBIO.
Role :
- Eligible chemical substances are curated from the example section of the patents in custom designed formats
Project #3 :
Project : Biomarker database
Duration : April 2007 to Jan 2009
Software : ISIS-Draw, ISIS-Base, GOBIOM (GVK Online biomarker)
Team size : 30
Description :
Biomarkers are emerging as an essential tool to boost efficiency in the field of drug discovery. Around 90% of new compounds fail during the clinical trials, predominantly related to absorption, distribution, metabolism, excretion (ADME) and toxicity issues. Biomarkers increase productivity by identifying potential drug failures at an early stage thereby saving costs and time in the long term. These are used in clinical trials as validated surrogate endpoints when approved by regulatory bodies. Curation of journals included in ClinicalTrials.gov, ASCO, GSK and PubMed for different biomarkers (biochemical, genomic and imaging) which cover a wide therapeutic area such as Oncology, Cardiovascular, Musculoskeletal, Urinogenital, Respiratory etc. Database is generated with information like Biomarker summary, Clinical validation, Analytical validation, Biomarker statistics, and Pharmacokinetics, Pharmocodynamics, Clinical Trial Details and Patient Demographic information.
Role :
- Curating the biomarkers from different journals
- Quality Analyst which includes maintaining the quality of the reaction records information through review.
Project #4 :
Project : Drug database (launched drugs)
Duration : Oct 2006 to April 2007
Software : ISIS-Draw, ISIS-Base, Chem-Draw and Oracle 9i
Team size : 10
Description:

Database of launched drugs (which are approved by FDA and Marketed) with their clinical, preclinical, pharmacokinetic, metabolism including toxic mechanism in animal models and humans along with target information. The drug database is a unique bioinformatics and cheminformatics resource that combines detailed drug (i.e. chemical, pharmacological and pharmaceutical) data with comprehensive drug target (i.e. sequence, structure, and pathway) information. Each DrugCard entry contains more than 100 data fields with half of the information being devoted to drug/chemical data and the other half devoted to drug target or protein data.
Role:
- Particular drugs are curated in customdesigned formats.
Project #5:
Project : Target Database
Duration : August 2005 to Oct 2006
Software : ISIS-Draw, ISIS-Base, Chem-Draw (Sci-Base GVK Online tool)
Team size : 15
Description:
Curation of information from Patents, Journals where chemical, biological and pharmacological information on a number of biologically active compounds that are
active against a given target or set of targets, data on multiple bioactivities and ADME
properties, information on 3D-chemical structure, preparation methods, biological
activity, bioassays of targets and related diseases.
Curation of Pharmacokinetic Data and Assay information of drugs, prodrugs and other compounds involving the ADMET information such as oral availability, urinary excretion, bound in plasma, clearance, volume distribution, half life, number and nature of metabolites, metabolite enzyme information, effective concentration and toxic concentration, cell assay for in vitro and various animal model studies for in vivo studies.
Role:
- Particular target is curated in custom designed formats to meet specific client requirements.

[Guest]


NOUFAL.K
Email : noufal365 AT gmail.com



RESUME

OBJECTIVE
Looking forward for a challenging work atmosphere leading to a professional experience where my skills will be utilized to the fullest for the mutual benefit.
PROFESSIONAL EXPERIENCE
More than One and Half year experience in clinical research industry.
Have SEVEN month experience as a Clinical Research Nurse Co- ordinator(CRNC)
/Clinical Research Coordinator(CRC) in ALTREE LAB Pvt.Ltd Cochin, where I have worked on therapeutic area of Hypertension
I have One year experience as a Clinical Research Co-coordinator(CRC) in Manipal Acunova(Manipal Centere for Clinical Research), Kasturba Medical College, Mangalore, with therapeutic area of experience in Type II Diabetes Mellitus and Metabolic Dysfunction
Previous Experience in Clinical Trials :
Sl No.
Indication
Clinical Phase of Trials
Year
1
Metabolic Dysfunction
III
2010
2
Type II Diabetes Mellitus
IV/ASSESSMENT
2010
3
Hypertension
II AND III
2010-till date
Have experience as a Clinical Nurse in KIDWAI ONCOLOGY HOSPITAL Bangalore
Job Responsibilities :
Overview and monitor throughout trial period.
Liaise with Principal investigator/Co-Investigator, other health professionals, and Sponsor.
Contact patients regarding recruitment,explanation of trials,consent,follow-up and counseling.
Ensure ethics committee receives safety notifications and other study related information as per regulatory requirements.
Ensure Clinical Trials are conducted according to Protocols.
Visit Scheduling and Follow up of patients as per protocol specifications.
AE/SAE management.
Organize diagnostic investigations/reports as per trial protocols.
Monitor correct functioning of trial equipment.
Collect ,records and maintain trial data as per protocol.

Certified Computer Course in MS Dos and WINDOWS
Udaya Computer Education centre Meppayur
FIELD OF INTEREST
Site Co-ordination, Monitoring& Management Activities.
EXTENSIVE KNOWLEDGE
CRF filling.
Performing IP management
Assisting Ethics Committee correspondence
Assisting ICD process
Performing Patient counseling for study compliance.
Assisting in patient recruitment & Counselling.
GUIDELINES
ICH-GCP Guidelines & Indian GCP.
Regulatory Guidelines (Schedule Y, US-FDA).
ICMR Guidelines.
IN-DEPTH KNOWLEDGE IN
Pharmacology, General Pharmacology, ANS, CNS, and CV drugs, GI drugs, Autocoids, Hormones, drug effecting blood and blood formation, antimicrobial drugs, chemotherapy and misc. drugs.
Therapeutics/Disease – Hyper parathyroidism, diabetes mellitus, congestive cardiac failure.
Regulatory Affairs- Introduction to pharma relation, patency and regulation, pharma regulatory for import and export, clinical trial and regulations, GMP an regulatory compliance for pharma and bio-tech products.untitled folder
Clinical Data Management- Data Acquisitions, CDM work flow, Data Entry and Data Processing, Data Base Set-up, Data Base Validation, Quality Check and safety data management reporting.
Pharmacovigilance – detection, assessment, understanding and prevention of adverse effects.
Biostatistics – Basics of Biostatistics.
Electronic Data Management Skill
EDC Software : Oracle(eCRF), Inform (eCRF)
Packages : MS office suite

[Guest]

RESUME
NAME SUDESHNA LAMA

E-MAIL ID sudeshna_lama AT yahoo.com


AIM :
To work towards the betterment of the Company,give justice to the job assigned to me,gain experience, explore my potential ,learn and excel . To strive to reach the acme of my career.


OBJECTIVE :
I am seeking a job in your Company,so that I can make a proper utilization of my skills and knowledge such that I benefit my company as well as grow in experience with hard work ,commitment and dedication.I shall put in my very best in delivering quality work which is required of me.I shall be flexible in learning new skills which will assist me in my job.

SKILLS :
1) Knowledge of :

i) Drug development, phases of Clinical trials and Clinical Research
ii) GCP, Schedule Y and other regulatory requirements.
iii) Pharmacovigilance
iv) Clinical Data Management

2) Proficient in MS Office(Word, Excel, Power Point) and Internet applications

3) Strong written and verbal communication skills

4) Independent worker , can work under minimum supervision

5) Comfortable in interacting with people from all walks of life

6) Team player

7) Flexible with adopting and learning new techniques /skills which shall enable me to increase my productivity and knowledge

8) Good organizing abilities

9) Eye for details and detecting flaws.




EDUCATIONAL QUALIFICATIONS :
BOARD YEAR OF PASSING INSTITUTE PERCENTAGE DIVISION
1) ICSE 2000 LORETO CONVENT DARJEELING 84.3% I
2) AISSCE(CBSE) 2002 SRI SATYA SAI VIDHYA VIHAR,NEW DELHI 70% I
3) B.Sc (Chemistry honours) 2005 ST JOSEPH’S COLLEGE,
DARJEELING 50.2% II
4) M.Sc(Chemistry) 2007 NORTH BENGAL UNIVERSITY,
SILIGURI 65% I


PROFESSIONAL QUALIFICATION :
Post Graduate Diploma course in Advanced Clinical Research from
Institute of Clinical Research India,Bangalore Campus.



CERTIFICATIONS :
Certificate of GHP (Good Handling Practice) Competency-Green Belt Certification awarded by Max Medisupport Pvt. Ltd.


WORK EXPERIENCE :
EMPLOYER DESIGNATION DURATION
1) ST JOSEPH’S COLLEGE,
DARJEELING. PART -TIME LECTURER IN CHEMISTRY SEPTEMBER 2008-DECEMBER 2009
2) DARJEELING GOVERNMENT COLLEGE,
DARJEELING. PART -TIME LECTURER IN CHEMISTRY OCTOBER 2007-JUNE 2010


DUTIES PERFORMED :

As a Part time Lecturer in Chemistry ,I conducted lectures and practical classes for I, II and III year ( Chemistry Honours and General Science students)


WHAT I LEARNED FROM MY PREVIOUS WORK :

Ability to handle and control a large number of people,public speaking,I learnt to express myself clearly and work hard.