www.clinexa.com Life Sciences Pvt Ltd Hyderabad : Clinical Research Associate

[muthukalee]

Clinical Research Associates
Primary responsibility is to accurately monitor and train clinical research sites.

Qualifications :
* Life Science Post Graduate/B.Pharma
* Knowledge of Indian and International Clinical trial regulations.
* Interest in research methodology.
* Detail oriented.
* Good organizational skills and team player.
* Ability to work independently.
* Innovative and creative.
* Flexibility.
* People oriented.
* Good interaction skills with patients.
* Certification in clinical research preferred.
* Willingness to travel 40 - 50% of time.

If you wish to be part of an exciting, dynamic company at the forefront of Indian Clinical Research please contact our resourcing team at hr@clinexa.com

About us :
Clinexa Life Sciences Pvt Ltd is a full-service Contract Research Organization (CRO) with extended clinical research capabilities having a distinguished investigator network throughout India offering comprehensive clinical research and site management services to Pharmaceutical and Biotechnology companies, Contract Research Organizations etc. Following the guidelines for re-engineering the clinical research enterprise as outlined in the NIH-Road Map for medical research we aim to contribute to accelerating and strengthening clinical research by adopting a systematic infrastructure that will better serve the evolving field of scientific discovery.

Contact us :
Clinexa Life Sciences Pvt Ltd.
501, 5th Floor
V V Vintage Boulevard,
Raj Bhavan Road, Somajiguda,
Hyderabad - 500082
Andhra Pradesh, India

http://www.clinexa.com/

[Guest-IJT]

Name : shankar
Email : nawab_shankar AT yahoo.co.in
Designation / Skillset : clinical research associate/CRA/- Positive Attitude, Determined, High Energies. - Hard Working, and Sincere. - Good decision making and analytical skills./Able to handle people in a very efficient way..
To Evolve as a Successful Professional in Clinical Trials Management in Clinical Research Organizations with my skills, abilities in a dynamic, professional, creative and research environment.

Resume :
CAREER OBJECTIVE :
To Evolve as a Successful Professional in Clinical Trials Management in Clinical Research Organizations with my skills, abilities in a dynamic, professional, creative and research environment.
PROFESSIONAL EXPERIENCE :
- Working as Clinical Research Associate at Vimta Labs, Cherlapally, Hyderabad from January 2008 to August 2010.
- From September- 2010 working as Clinical Research Associate at Aizant Drug Research Solutions Dullapally, Hyderabad till date.
Responsibilities :
Clinical Pharmacist (from Jan 2008 to Nov 2009).
- As a Pharmacy in charge responsible for Maintaining Pharmacy Log books and related documentation.
- IPs (Investigation products) Receiving from the sponsor, IPs Storage as storage temperature mentioned on the container label.
- Maintained Accountability of Investigational Products and Retention as per applicable regulatory guidelines.
- Drug Receipt Record, and communicate to sponsor regarding IP discrepancies.
- Preparation of dispensing Labels for dispensing container/sachets/vials as per Randomization.
- Dispensing of investigational products (i.e. solid Oral dosage forms and Suspensions, also Parenterals) Retention of balance Investigational Products.
- Dosing of Investigational products to study subjects as per Randomization.
- Dispatch/Disposal and Return of Investigational products,
- Calibration and maintenance/ Annual maintenance of humidity chamber and Refrigerators, documentation of study activities.
- Continuous monitoring of trials according to ICH / GCP and other applicable regulatory guidelines.
CRA (Clinical Research Associate :
- Documents preparation, Execution of protocol specified procedures, presenting trial protocols to a steering committee.
- Protocol compliance, Clinical Studies monitoring as study CRA.
- Planning and execution of all clinical studies in accordance with SOPs and ICH-GCP, Schedule-Y compliance and applicable regulatory requirements.
- Adherence to the protocol, Source documentation verification and data query clarification.
- Ensuring appropriate study materials are sent to the investigational site before the planned initiation date.
- Ensuring that the required regulatory documents( i.e. Signature and dated Confidentiality & Non Disclosure agreement, study trial Agreement, Signed and dated Investigator C.V, copy of current medical registration certificate , Signed and dated Investigator Undertaking and FDA form 1572, financial disclosure forms and IRB/IEC Approval.
- Communicating with the Sponsors, Interact with the investigator and IRB/IEC.
- Coordinating translation of applicable study documents (e.g. ICF, etc.).
- Ensuring proper AE and SAE reporting and documented follow up and reporting requirements for SAE and safety events to sponsor and IRB/IEC.
- Assist in the compilation of the study related documents during the pre-trial period.
- Assist in the process of administering the Informed Consent to subjects and discussing in detail the Patient Information Sheet & Patient Diaries.
- Follow up with site team for timely completion of the source documents and ensuring that all the relevant information required in the CRF are present in the source document.
- Complete the Case Record Forms within the timelines and with minimal errors.
- Schedule subject visits as per the Protocol to ensure maximal subject compliance & retention.
- Coordinate all central laboratory related activities, sampling procedure, shipment of samples through the designated courier and ensure timely receipt of the lab reports
- Compile and update the Master File within timeline
- Worked with Monitors in completing of training of team at site regarding GCP, Protocol, Safety Reporting, maintenance of essential documents & regulatory documents such as Ethics Committee submission and other regulatory requirements.
- Maintain the study related logs : Screening, Enrolment, Delegation, Drug administration, Temperature and other communication logs
- Responsible for the management of study materials and supplies : Distribution, Ordering, Tracking, Storage, Reconciliation and Destruction.
- Coordinating with the PI, CI and Other study personnel during the study.
During the study I would be ensuring the fallowing :
- Informed Consent Forms, Subject Eligibility & Source documents
- Case report Forms
- Investigational Product dispensing & Accountability Log
- Study Master file
- Investigational Product, Lab kits storage area & records.
- Safety & PK samples storage and processing records.
..
Quality System Experience :
- ISO/IEC 17025,ISO 15189
- CGMP
- CH-GCP
ACADEMIC PROFILE :
- B. Pharmacy (2003- 2007) in Bharat Institute of Technology and Pharmacy awarded with first division (64%) from Jawaharlal Nehru Technological University, Hyderabad, A.P.
- Intermediate (1999 – 2001) in APSWRJC awarded with first division (60%) from Board of Intermediate, A.P.
- S.S.C (1998 – 99) from APSWRJC with first division (66 %)..
PROJECTS PROFILE :
- Project work carried out in the Institution on “Pharmacological Evaluation of Antiarthitic activity of Aegle marmelos” under the guidance of Asst.Prof. Soujanya.
WORKSHOP ATTENDED :
- Participated in Workshop on GCP Conducted by ASSANSA on 2009/11/12.
- Attended workshop on BA/BE Studies conducted by Pharmantra consultants in Feb 2008.
PERSONAL SKILLS :
- Positive Attitude, Determined, High Energies.
- Hard Working, and Sincere.
- Good decision making and analytical skills.
- Able to handle people in a very efficient way.
Additional Information :
- Participated in Indian pharmaceutical congress as volunteer.
- Participated in several elocution and Debate contests.
- Visited Hetero Drugs, IPL Reddy’s Lab in Hyderabad, Trained at Concord Drugs Ltd, Hyd.
- Undergone pharmacy training at Yashoda hospital, Secunderabad.
DECLARATION :
I hereby declare that all the above-mentioned details are true to the best of my knowledge and belief.
Date :
Place : Hyderabad. Alkapally Shankar
-------------------------------------------------------
More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4172758
Date & Time : 25th May 2011 3:14 PM (UTC)
IP Address : 115.252.109.164
Browser Info : Mozilla/5.0 (Windows; U; Windows NT 5.1; en-US; rv:1.9.2.17) Gecko/20110420 Firefox/3.6.17
Predicted Country : India

[kewatkar.shailesh]

sir i am waiting for your reply

[Guest]

Shyam Therala
shyam.teraala AT gmail.com
CAREER OBJECTIVE
To build a promising career in a well-reputed organization compatible with my academic qualifications, professional skills, personal strengths, where I can explore myself fully, grow along with the organization to achieve better positions
EDUCATION
- Trained in Clinical Research modules like CRA,CDM , Pharmacovigilance , IPR and SAS from Clinnov8 Research Labs, Hyderabad in 2010
- Bachelor of Pharmacy from J.S.S College of Pharmacy, Mysore in 2006
WORK EXPERIENCE
May 2009 till date Territory Manager Emcure Pharmaceuticals Pvt. Limited
October 2007 – April 2009 Medical Representative Ranbaxy Laboratories Limited
Organization : Emcure Pharmaceuticals Pvt. Limited
Title : Territory Manager covering Hyderabad Head quarter
Roles and Responsibilities :
- Maintain effective relationship with Doctors, Chemists and Distributors.
- Coordinate with CFA, Distributors and Retailers for effective functioning of distribution process.
- Coordinate with sales field personnel, ABM’s and ZBM.
- Plan and implement the existing strategies of the company by conducting promotional campaigns.
- Provide necessary scientific information to the doctors.
- Deal with institutions such as railways and A.P.S.R.T.C to get bulk business
Achievements
- Increased the secondary sales from 30 lacs to 65 lacs for the year 2009-2010
- Worked out relationship sales
- Qualified for incentives and earned a laptop for achieving annual target
________________________________________
Organization : Ranbaxy Laboratories Limited
Title : Medical Representative
Roles and Responsibilities :
- Identify potential doctors by making a retail survey.
- Target right products to right doctors.
- Monitor the sales of the brands by regular follow up of doctors, chemists and distributors.
- Achieve the sales target every month by performing consistently.
- Assist the team in closing sales.
- Ground Line Function covering Davangere, Chalkere, Chitradurga, Jaglur, Ranebennur, Harihara, Shimoga & Badravathi based at Davangere
- Attain defined annual sales objectives at the territory level
- Promote the company’s products, image and reputation
- Management and development of the region
- Therapeutic Segments Handled : Cardio-Diabetic products covering Cardiologists, Diabetologists & Physicians
- Immediate plan : To bring in good motivating working systems that will help develop customers, brands & sales; thereby become No. 1 Territory in the region within a year’s time.
- Achievements :
o Best Detailer Award with Swatch watch
o Achieved the sales targets for 1.8 yrs by performing consistently throughout the year.
o Achieved a growth rate of 15% consecutively for 1.8yrs.
o Consecutive achievement for incentives of the year 2007
________________________________________
COMPETENCIES
- Brand building activities
- Relationship marketing
- In-depth therapeutic and clinical research expertise as well as knowledge of ICH – GCP and applicable regulatory guidelines
- Excellent understanding of clinical trial methodology, GCP, Medical terminologies
- Excellent understanding of physiology, pharmacology, clinical study objectives, drug development process, fundamentals of clinical operation
- Knowledge of design of Case Report Form (CRF) and protocol design.
- Better Understanding safety issues in Pharmacovigilance.
- Good knowledge of Adverse Events/Serious Adverse Events.
- Ensure compliance with company policies and SOP’s.
COMPUTER SKILLS
- MS Office
- Windows XP
STRENGTHS
- Result oriented and strive hard to achieve the desired result
- Willingness to learn without any hesitation
- Ability to maintain effective communication and relation with peers and superiors
- Leadership qualities focusing team & organization growth
- Experienced in pharmaceutical specialty segments
- Good team administration & analytical skills

[muralisollu]

MURALI. SOLLU
E-Mail :muralisollu AT gmail.com
CAREER OBJECTIVE :
To secure a challenging career opportunity in your organization and to excel as a Successful Employee in your esteemed organization and to strive for the growth of it by becoming the part of the team that dynamically works towards the growth of it.
EDUCATIONAL QUALIFICATIONS :
S.NO Qualification Board/university Percentage
1 M.Pharmacy
(Pharmacology) Osmania university 70.21%
2 B.Pharmacy Kakatiya university 68.87%
3 D.Pharmacy SBTET 74.5%
GATE Score percentile : 70.52
THESIS WORK :
Entitled as “Investigation on anti-mutagenic activity of Carthamus tinctorius oil in mice”
SOFT SKILLS :
- Operating Systems : Windows 98/2000/XP Professional/Vista/Windows7
- Packages : Ms-Office
TECHNICAL SKILLS :
- I have good knowledge on ICH-GCP guidelines and OECD guidelines.
PROFESSIONAL TRAINING :
I have undergone Training in Analytical techniques in a Symphony Pharma Life Sciences, Turkapally, Hyderabad, during year 2009 for duration of one month.
PUBLICATIONS :
- Review article entitled “An appraisal on Causes and Treatment of Diabetes Mellitus” in Der Pharmacia Lettre.
- I have sent research paper entitled “Investigation on anti-mutagenic activity of Carthamus tinctorius oil in mice” to Indian Journal of Experimental Biology.

[Guest]

Curriculum Vitae
G.Gayatri
E Mail ID : gayatri123rama AT gmail.com
OBJECTIVE :
To be a successful pharmacologist and to enter into a field where my skills will be enhanced and cope up with the upgrading technologies and to contribute to pharmacy team as a good researcher.
ACADEMIC PROFILE :
S. No.
Education
Institution
Year Of Passing
Percentage
1 Master of Pharmacy
(Pharmacology) Vagdevi College of Pharmacy and Research Centre, Nellore.
.
2011
69%
2 Bachelor of Pharmacy Aditya College of pharmaceutical Sciences and Research, Surampalem. 2009 69%
3
Intermediate Aditya junior college, Kakinada. 2004 92%
4 SSC Aditya Public School, Kakinada. 2002 89%

SCHOLASTIC ACHIEVEMENTS :
o Qualified in GATE-2009 with a percentile of 86.24.
o Stood Second rank in 10th class at School Level with overall percentage of 89%.
o Received Prathibha award in 7th std at School level.
SKILLS :
1. Handling of Mice and Rats.
2. Routes of Drug administration : I/V, I/P, S/C, I/M, Per Oral.
3. Anaesthesia of animals.
4. Blood collection techniques : Tail vein puncture, Tail cut method, Cardiac puncture.
5. Determination of Blood sugar levels in rats.
6. Bioassays : Matching, Bracketting, Interpolation, Two-point and Three-point bioassays using rectus abdominus muscle of frog.
7. Separation of Plasma and Serum.
INSTRUMENTS HANDLED :
Electronic von Frey, Tail-Flick analgesiometer, Hargreave’s Plantar Test, Randal-Selitto analgesiometer, Digital Plethysmometer, Rota rod, Actophotometer, Chymograph.
COMPUTER SKILLS :
MS-Word, MS-Excel.

PROJECTS DONE :
M.Pharm Major Project :
I have done a project entitled “A reproducibility study of three different dosing regimens of paclitaxel induced neuropathy in rats” in Vimta Labs for a period of 6 months.
Description of project :
Paclitaxel ,an anticancer drug, causes neuropathic pain characterized by Hyperalgesia, Hypoalgesia and Allodynia which can be simulated in animals using thermal and mechanical stimuli. Three different doses of paclitaxel were administered intraperitoneally to three different groups of S.D rats and its response to thermal stimuli was determined using Plantar test and response to mechanical stimuli was analyzed using Electronic von Frey and Randal-Selitto test. In this study, reproducibility of three different dosage regimens of paclitaxel was tested to identify the optimal dose and dosing regimen of paclitaxel that closely mimics signs of human neuropathy and can be adapted routinely to test analgesic drugs in chemotherapy induced model of neuropathic pain
M.Pharm 1st year mini project :
Effect of Mimosa pudica leaf Extract on wound healing of streptozotocin induced Diabetic rats.
INDUSTRIAL TRAINING :
I have undergone industrial training in Q.C department in Smilax labs, Hyderabad for a period of 2 months in B.pharmacy.
PERSONAL DETAILS :
Father’s Name : G.Prabhakara rao.
Mother’s Name : G.Rama Devi.
Date of Birth : 12-Feb-1987.
Sex : .
Religion & Nationality : Hindu, Indian.
Languages Known : English and Telugu.
Course of Study : M-Pharmacy (Pharmacology)
Name of the College/University : Vagdevi College of Pharmacy and Research Center, JNTU.

[Guest]

Respected sir,
i send my resume i am very interested to work in CRO industry,i have 2 years experienced,i trained students in clinical trials along with BASE SAS.

[Guest]

CURRICULUM VITAE
S.VASUDHA NAGINI
E-mail : vasudhasvn AT gmail.com

Career objective :
Seeking a challenging career and development environment, which bring my potentials out, and credit to my employment.
Work skills :
- Worked in Oriens Scientific Innovations Private Limited, Bangalore (9 months) as Technical Associate R & D by Project Execution of Minimally Processed Tender Coconut & Accomplishment of Pre-Prepared Microbiological Media Plates Production, Development and Quality.
- As a Technical associate have played a key role in search of scientific journals and articles through internet and worked on documentation of laboratory thorough process, understanding by generating and evaluating the data during lab scale experimentations in compliance with GMP & HACCP guidelines.
- Have good written and verbal communication, presentation skills, and ability to relate effectively with of scientific and professional officials.
- Ability to work independently as well as in a team environment; strong interpersonal skills, problem solving ability, ability to learn, creativity and professionalism.
Soft skills :
- Familiar in operating systems (WIN XP,VISTA), Micro soft word ,Excel, Internet software (MS Internet Explorer), MS Paint and Power Point presentation skills.
- Confidence in taking up any new challenges and successfully completing it. Coordinating work and liaising with various tasks in a department that involves considerable inter personal skills. Adaptability and flexibility including ability to manage pressure, ambiguity and change.
Conference Attended
- Participated in the 35 th Association Of Clinical Bio chemists In India (ACBIOCON) conducted in Calcutta in November 2008.
- Lecture work shop on “Advances in Biological Sciences”2011 conducted by PPISR Bangalore.
Credentials :
Qualifications University/Board College/School Year of
Passing Percentage of Marks
M. Sc Medical Biochemistry
Duration : 3Yrs specialization NTR University Of Health Sciences, Vijayawada GSL Medical College, Rajahmundry 2009 69%
First
B. Sc (Biochemistry, Microbiology, Medical lab technology)
Duration : 3Yrs Andhra University, Vizag Al-Ameer Institute of Management &
Technology 2006 76%
First
Intermediate Board of Intermediate Andhra Pradesh Usha Junior College, Rajahmundry 2003 60%
First
S. S. C School of secondary Education N.K.V. High School, Rajahmundry 2001 80%
First
Project work during Master degree

During my Masters (Medical Biochemistry), I worked on electrolyte estimation in serum and urine samples of hypersensitive patients. Dissertation thesis entitled “Estimation Of Serum Na+, K+, Mg+2, Protein & their Correlation with urine Na+, K+ & Micro-Protein in hypertensive cases”.

[Guest]

RESUME
E-mail-id : krishraj1988 AT gmail.com
Madigoni Krishna goud.

Career Objective
To be a part of an organization which will provide good working environment and encourage to innovate new things which will sharpen my creative thinking to strive utmost for the development of the body.

Project details :
I have done my project in the field of Pharmacognosy entitled “EXTRACTION OF ALOIN FROM ALOE VERA AND ITS ANTI MICROBIAL ACTIVITY”

Technical Skills :
I have done industrial training for one month which covers ware housing, research and development, bulk production, quality control and storage departments in ACCRETE PHARMACEUTICALS PVT LIMITED, Koylagudem (V), Choutuppal (M), Nalgonda dist.

Academic Profile :
Examination Board/University Percentage Year of passing
S.S.C Mallikarjuna high school, Choutuppal (V)&(M), Nalgonda dist. 72.00% 2003
Intermediate Sri chaitanya junior college, Choutuppal (V) &(M), Nalgonda dist. 76.00% 2005
Bachelor in Pharmacy Netaji institute of pharmaceutical sciences, Toopranpet (V), Choutuppal(M), Nalgonda dist. 67.00% 2011

Strengths :
- Zeal to take up new challenges.
- Self-confidence.
- Good team-building skills and leadership qualities.
- A quick learner with “Can do attitude”.

Experience :
I have got no experience and applying as a fresher as the course of study completed in the year 2011.