Clinigene International Ltd Bangalore : Clinical Research Associate

[muthukalee]

Department :Clinical Operations

Position : Clinical Research Associate

Qualification :Post graduate in life science / B.D.S / MBBS / M. Pharmacy / B. Pharmacy.

Experience : 2 - 4 years.

No. of Position : 4

Location : Bangalore

Job Description :
* Assist Project Manager with feasibility analysis and identification, and selection of investigators.
* Assist Project Manager in planning the conduct of the clinical trial and developing trial management systems.
* Assist in preparation of study budgets.
* Prepare documents for ethics committee and regulatory submissions.
* Assist in the planning and coordination of investigator meetings and prepare presentation materials and present information at these meetings.
* Assist in the management of recruitment strategies, when necessary.
* Assist in the management and preparation of tracking documents.
* Assist Project Manager with management of study drug/supply/equipment delivery, shipment, inventory, and accountability.
* Create documents required by the project team prior to the start of the study (e.g. protocols, feasibility questionnaires, patient tracking tools, etc.).
* Prepare, plan, organize and conduct pre-study (site selection) visits and report on these visits to Project Manager to assist in site selection.
* Prepare, plan, organize and conduct site initiation visits.
* Collect and review essential documents from study sites.

Candidate Profile :
The Senior CRA monitors projects under minimal supervision, supports the Project Manager and provides input to the feasibility, planning, investigator selection, budgeting, logistics, conduct and reporting of the study. The Senior CRA may be called on to serve as a mentor to junior CRAs and/or to undertake special projects or roles relating to project management.

Apply : careers@clinigeneintl.com

About us :
Established in the year 2000 as a Biocon subsidiary, Clinigene became India's first CAP (College of American Pathologists) accredited Central Laboratory. Clinigene's services now span a broad spectrum of activities including human pharmacology, bioanalytical research, central laboratory, clinical operations, medical writing, medical monitoring, safety management, pharmacovigilance, clinical data management & biostatistics and regulatory services supporting early-phase through late-phase clinical development programs.

Contact us:
Clinigene International Limited
"Clinigene House",
Tower 1, Semicon Park
Electronic City, Phase II,
Hosur Road, Bangalore - 560100, India
http://www.clinigeneintl.com/

[Guest-IJT]

Name : KULDEEP KINJA
Email : kkinja_pharma AT yahoo.com
Designation / Skillset : CLINICAL RESEARCH ASSOCIATE (CRA)
I have completed my M Pharma in Pharmacology and also done an Industrial Diploma in Clinical research and Pharmacovigilance. I have a keen interest in Clinical research and want to make it as my career. I have a through theoretical knowledge of clinical trials and just need one chance to show my skills. I am looking for a job profile of as CRA.

Resume :
Objective :
Intend to build a career with leading corporate of hi tech environment with committed &dedicated people, which will help to explore myself fully and realize my potential. To apply best of my skills and efforts to excel in the field of Pharmaceutical research.
Professional Qualifications :
- M Pharm (Pharmacology) from NIMS Institute of Pharmacy, NIMS University, Jaipur, Rajasthan.
- Industrial Diploma in Clinical Research and Pharmacovigilance (Distance Mode) from Aryabhatta Clinical Research Consultancy and Education Institute, Udupi, Karnataka.
- B Pharm with 1st division from B.S.A Institute of Pharmacy Faridabad. University- M.D.U Rohtak, Haryana.
Academic Qualifications :

Degree University/Board Year Percentage Division
(%)
M Pharm 1st Yr. NIMS University Jaipur 2010 70 1st
B Pharm M.D.U Rohtak 2009 74 1st
10+2 (PCB) CBSE New Delhi 2004 75 1st
Matriculation CBSE New Delhi 2002 79 1st
_____________________________________________________________________________________
Title of Project :
Title of M.Pharma project work is ‘Substitution of Drugs in Unani System- A Pharmacological Viewpoint Evaluation’.
Guided By : - Dr. K.C Singhal.
Areas of Interest :
- Research and Development
- Clinical Research
Research Papers/ Review Article Published :
1) Title- “A Review on Biomarkers as Diagnostic Tools” in International Journal of Pharmaceutical Sciences Review and Research (IJPSRR), Volume 7, Issue 1, March – April 2011.
2) Title- “A Review on Hereditary Disorders” in Journal of Pharmaceutical And Biomedical Sciences (JPBMS), Vol. 05, Issue 05, April 2011.
3) Title- “Antidiabetic Activity of the Alcoholic Extract of the Aerial Part of Boerhaavia Diffusa in Rats” in Recent Research in Science and Technology (RRST), Vol. 03, Issue 07, April 2011.
4) Title- “In-vitro comparative antioxidant activity of Ethanolic extracts of Glycosmis pentaphylla and Bauhinia variegate” in Recent Research in Science and Technology (RRST), Vol. 03, Issue 07, April 2011.
5) Title- “A review on Liver disorders” in International Journal of Research in Ayurveda and Pharmacy (IJRAP), Vol. 02, Issue 02, April 2011.
6) Title- “A Review on ‘Anti-Angiogenic Therapy’-Past Present and Future” in Recent Research in Science and Technology (RRST), Vol. 03, Issue 07, April 2011.
Research Papers/ Review Article (In Correspondence) :
1) A review on Hutchinson - Gilford syndrome- “Progeria”.
2) A review on inflammation.
3) ‘Parkinsonism : a major neurological disorder’.
4) A Review on “Churg-Strauss Vasculitis”.
5) A Review on Experimental Models for “Evaluation of Hepatoprotective Activity”.
Computer and Other Skills :
- Operating System- Windows 7/Vista/Xp/Me/2000
- Fluent in MS Office ( Word, PowerPoint, Excel )
- Working Knowledge of handling of instruments like UV-Visible Spectrophotometer, Flame Photometer.
Summer Training in B.Pharm :
MEDICAMEN BIOTECH Limited
Industrial Area Phase-IV Bhiwadi (Rajasthan)
Period- 60 Days
Worked In- Production (Tablets, Capsules & Oral Liquids) Quality Control &
Microbiology Lab.
Seminars Attended :
- Attended International Symposium On “The Future Vision & Challenges in Pharmacy Profession” at B M Birla Auditorium Jaipur on 18-19 September 2010.
- Attended 27th Annual Conference of ‘Indian Academy Of Neurosciences’ at NIMS University, Jaipur on 18-20 December 2009.
- Attended National level seminar conducted by APTI (Haryana branch) at JCD College of Pharmacy, Sirsa on 21 Feb 2009 on “Emerging Trends in Drug Delivery”.
- Attended Seminars on “Role of State Pharmacy Council in present scenario” & “Role of Hospital Pharmacy in present scenario” in college campus.
- Attended Guest Lectures on Mechanism of Hormone action, Process Validation, Nanotechnology in Cosmetics, Power & Duties of Drug Inspector, Role of CPCSEA and GMP- Need of Hour in college campus.
Cultural and Other Activities :
- Presented Poster on Topic “Adverse Drug Reactions and Its Monitoring” at NIMS University, Jaipur on 20 Jan 2010.
- Participated in Oral Presentation on Topic “Pharmacy In 2020” at NIMS University, Jaipur on 20 Jan 2010.
- Represented my School at Regional Level in Hockey in session 1998-99.
- Participated in different games like Cricket, Hockey, Table Tennis, Badminton, Volleyball at School and College level.
- Participated in many Co-curricular activities like Dance, Skit, Play, and Anchoring at School and College level.
Affirmation
I consider myself familiar with pharmaceutical Aspects. I am also confident of my ability to work in a team. I hereby declare that all the information furnished in this application is complete and correct best of my knowledge and belief.

Date- 25 May 2011
Place- New Delhi Kuldeep Kinja
References :
- Dr. K.C Singhal
M.D, PhD
Vice Chancellor
NIMS University, Jaipur.
- Mr. Nakul Gupta
M.Pharma
Asso. Professor
NIMS University, Jaipur.
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More Information about this submission and submitter :-
___________________________________________________
Submission ID : 4170136
Date & Time : 24th May 2011 10:20 PM (UTC)
IP Address : 27.107.152.232
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[Guest]

SANTHOSH YL
Bangalore - Karnataka e-mail : santosh.kvc AT gmail.com
CAREER OBJECTIVES
- To pursue a challenging career in the area of Pharmacy to become a part of esteemed organization that gives me scope to enhance my knowledge and skills, which results in my personal and professional growth as well as the growth of the organization.
EDUCATION
Educational Details
Exam
Passed Discipline Institute Year of
Passing Class
Obtained % Obtained
M.Pharm Pharmacy
Practice SAC College of Pharmacy, B.G.Nagara.

2009- 2011
Distinction
82.08%
B.Pharm
Pharmacy Sri KV College of Pharmacy, Chikballapur.
2004- 2008 Distinction 75.05%
CLINICAL PHARMACY ACTIVITIES DURING M.PHARM
Active participation in the following activities of Clinical Pharmacy at Adichuchanagir Hospital and Research Center, B.G.Nagara in various departments like General Medicine, Pediatrics, Orthopedics and Surgery from August 2008 to December 2010.
- Ward Round Participation and Medication Chart Review
- Provision of Drug and Poison Information
- Expertise in Bio-medical literature search by using different databases such as Micromedex, and Drug interaction checker for the provision of poison and drug information to the healthcare professionals.
- Adverse Drug Reaction Detection, Reporting, Monitoring, and Documentation
- Assessing suspected ADRs by using different causality assessment scales
- Reporting suspected ADRs to the CDSCO as a part of National Pharmacovigilance programme.
- Efficient in “Patient Counseling” and “Designing Patient Information Leaflets (PILS)”
M.PHARM DISSERTATION
‘EVALUATION OF THE IMPACT OF CLINICAL PHARMACIST PROVIDED PATIENT EDUCATION INTERVENTION ON HEALTH OUTCOME MEASURES OF TYPE II DIABETES MELLITUS IN RURAL POPULATION’
SKILLS
Personal skills :
- Good communication skills
- Time management
- Working efficiency and
- Guaranteed maintenance of documentations
Computer skills :
Well versed with Microsoft windows XP, Vista and windows 7, MS Word, MS Excel, MS power point, MS Access (2000, 2003 and 2007 versions), and Internet applications.
PROFESSIONAL CERTIFICATIONS :
1. ‘A National level Workshop on “PHAMACOVIGILANCE” program in KLE University Belgaum, Karnataka.
2. National level two days program me on “Modern Trends in PHARMACY PRACTICE” in association with AICTE in Amrita Viswa Vidyapeetham University, Kochi Kerala.
3. Participated in a National level Conference on Emerging Trends in Medicinal Plants Research a UGC Sponsored in Bangalore.
4. Attended Seminar on “Pharmacovigilence Program me” by Dr. Shobha Rani at SAC college of pharmacy, B.G.Nagara.
5. Workshop on Pharmaceutical Care” by Adepu Ramesh at SACP B.G.Nagara.
6. “Pharmacy Education in changing Global Scenario & New Career Opportunities” by B.G.Nagavai at SACP B.G.Nagara.
7. Attended a national conference on “New frontiers in Disease prevention/Cure” at BGS- Adichunchunagiri Biotechnology and Cancer research institute on 14th august
8. Participated in the national seminar “Research Implications and skills development techniques in pharmaceutical sciences”
9. Attended a national seminar on “Recent advances in pharmaceutical research” in SCS College of pharmacy, Harpanahalli on 12 September.
- PRESENTATIONS
- Presented a poster in 62nd Indian pharmaceutical Congress (IPC) Manipal entitled “Prevalence of type 2 diabetes mellitus in rural tertiary care hospital”
- Presented poster on
o “Identifying the age and drug use pattern through prescription audit and services in a community pharmacy of rural set up”, 2010
o “ABC Analysis of hospital pharmacy in a tertiary care teaching hospital”, 2010 in a IPA, RGUHS sponsored seminar at SACP
- Presented poster on “Hepatoprotective and antioxidant activity of ethanol extract of Mentha arvensis leaves against carbon tetrachloride induced hepatic damage in rats” in a national level at Bangalore at Maharani’s Science College, 2009
- National Symposium in markapur Andhra Pradesh accepted and presented the poster : “Estimation of RUTIN and QUERCETIN in TERMENALIA CHEBULA by HPTLC method”, 2008
- PUBLICATIONS :
- Has published 6 International publication
- Accepted to print : 3, under process: 2
- EXPERIENCES
1. Training Experience
- Involved in 150 hours Industrial training at Medo Pharma, Mallur (DST),Karnataka
2. Clinical Pharmacy Practice Experience
- Has 2 years of experience in providing clinical pharmacy services to Doctors in Adichunchagiri Hospital and Research Center, B.G.Nagara.
3. Community Pharmacy and Camps
- Underwent ‘Health Screening services’ in community set up for the rural population and coordinated the Pharm-D students in the camp
- Attended many free health check up camps organized by AH & RC, in and around Mandya district and coordinated the doctors in Medicines combinations, Prescription errors and Patient counseling to the medicines prescribed
Key Responsibilities include :
- Good understanding of ICH-GCP guidelines and Schedule-Y
- Documentation and maintenance of Source data
- Identification, Documentation and reporting of Adverse drug reactions
- Patient Counseling on medicines and disease
- Clarifying DCFs
CME/CPD PROGRAMS :
- CME on Thyroid disease : Management Then and Now by AIMS on 22nd October 2010
- 10 Strategies to Reduce Medication Errors ACPE Universal Program No. 0290-000-08-009-H05-P by Lauren S. Schlesselman , PharmD
- New Drugs of 2009, ACPE Universal Program No. 0290-0000-10-007-H01-P
- Connecting to Improve Practice : Online Drug Information and Professional Resources for Patient Care, ACPE# 207-000-10-007-H04-P by Ruth E. Nemire, BSPh, PharmD, EdD, RPh
- A Clinical Update in Diabetes Management ACPE ID No : 0798-0000-10-043-H01-P
- Clinical Urine Drug Testing During Opioid Therapy : A Case-Based Approach to Patient Monitoring by Bill McCarberg, MD ,Certificate ID: 1477512
AREAS OF SPECIAL INTEREST
- Clinical Research
- Clinical data management
- Drug safety Monitoring/ Pharmacovigilance
- Regulatory Affairs
- Teaching
- Hospital and clinical pharmacy services

[Guest]

E-Mail-smartvivek123 AT yahoo.co.in
VIVEK DINANATH PATIL
CARRIER OBJCECTIVE :
- A challenging career with a progressive organization which will utilize my skills, abilities and education in clinical research management, project management & clinical research operations, and be a part of the network towards the growth of the organization.
PROFESSIONAL EXPERIENCE :

NAME OF ORGANIZATION : COSMIC CLINICAL SERVICES Pvt. Ltd.
DESIGANATION : PROJECT COORDINATOR
WORK DURATION : March 2010 to till date
JOB PROFILE :
- Site Selection
- Pre-site, Pathology laboratory Audit
- Protocol training to study staff
- Protocol Development
- CRF Designing
- Preparation of ICF
- Communication with Investigators
- Clinical Trial Documentation
- Clinical Trial Logistics
NAME OF ORGANIZATION : BOMBAY BIORESEARCH CENTRE
DESIGANATION : PROJECT COORDINATOR / Sr. EXUCATIVE CLINICAL RESEARCH ASSOCIATE
WORK DURATION : March 2006- Feb.2010
JOB PROFILE :
- Communication with Investigators and Sponsors
- Protocol Development
- Operation of Biometric Software
- Staff Training
- Issue of Documents
- In House Clinical Trial Monitoring
- Regulatory Audit Preparation
AUDITS EXPERIENCED :
- Involved MCC regulatory audit in 2006-2007
- Involved Austria regulatory audit in 2007
- Involved WHO audit in Jan. 2008, mar.2008
- Involved USFDA regulatory audit in Aug. 2008.
- Insulin euglycemic clamp clinical study
EDUCATION :
Qualification Board/University Class Year of passing
H.S.C Mumbai Board Second
2000
B’pharm Pune University Higher Second
2004
Master in Clinical Research Dr. M G R University, Chennai First class 2006
M B A Guru Jambeshawar University,Hissar Second
2007
TRAINING UNDER TAKEN :
- One Month In-Plant Training In BAYER PHARMACEUTICAL. Ltd, Thane.
MAHARASHTRA.
In one month training I visited various departments like Production, Q.A. &Q.C, Packing, and Store.
In Production department I have seen the granulation process of tablet, manufacturing &Coating of tablet, manufacturing of Cream.
In Q.A. &Q.C. I observed & worked the various Q.C. tests. & Instruments
like HPLC, UV, IR.
In packaging department I observed the Blister packaging machine.
COMPUTER PROFICIENCY :
Having the knowledge of Microsoft word, excel & power point along with the surfing on internet.
Co-Curricular Activity :
- Attended 1st National Conference On Clinical Research, New Delhi 2004.
Presentation By : S.S.Agarwal (Dean, DIPSAR)
- I came to know about the ICH-GCP guidelines on clinical research.
- This seminar gave the regulatory information required for submission of new medicinal product.
Presentation By : Prof. S.K. KULKARNI (Advisor, Sun Pharma)
- I became aware about Regulatory Requirement for conduct the trial. (Schedule “Y” requirement)
- This seminar gives the detail about safety pharmacological studies
under compliance with GLP.
- Worked As Volunteer In 54th Indian Pharmaceutical Congress Held At Pune, 2002.
- Attended 12th International Seminar On Clinical Trial Management & Logistics, October 28th, 2005. Mumbai.
Extra-curricular activity
Worked As Volunteer In National Service Scheme 2003 –04.
- Worked In College Annual Magazine Publication.
- Worked In The “National Pharmacy Week”.

[Guest]

SRUTHI PRIYA DARSHINI.M
e-mail : msruthi8788 AT gmail.com

Career objectives :
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.
Education :
- MSc in Clinical Research from PRIST University in ICRI 2009-2011.
- PG Diploma in Pharma Business Management in ICRI during the year 2009 – 2010.
- BSc Nursing from Kamineni College of Nursing (NTR University) during the year 2004 – 2009.
- Intermediate(Bi.PC) from Sri Chaitanya Jr Kalasala during the year 2002-2004.
- SSC from Kamala High School in the year 2002.
Skill set :
- Participated in Hepatitis-B awareness campaign instituted by Shantha Biotechnics Ltd.
- Project on knowledge of mothers regarding personal hygiene of pre-school children,
NTR Nagar, HYD.
Experience :
Worked as Clinical Research Coordinator in Yashoda Hospitals for a period of 1 year.
While working,I have got hands on experience in :
- Assisting in Informed consent procedure
- Randomization procedures
- Using IVRS/IWRS
- Investigational Drugs handling, storage, dispensing
- Collection, processing and shipment of biological samples to Central labs
- Data management
- Writing and maintaining source documents of subjects.
- Checking Drug Compliance
- Completing eCRFs
- Resolving DCFs
-Maintaining IMP accountability and Temperature logs at site
- Reporting SAE/AE/Events to CRO and EC
- Coordinate all subject related appointments and investigations
Technical skills :
- Tele medicine from Chaitanya Medical Foundation, Bangalore .
- SAS and CDM from Clinovo, Hyderabad.
Area of interest :
Clinical Research Associate and Pharmacovigilance.