www.clintechresearch.com ClinTech Research India Pvt Ltd Lucknow : Clinical Research Associate

[muthukalee]

Clinical Research Associate (CRA)

Responsibilities:
* Perform routine site visits, including pre-study, initiation, interim, and closeout visits for Phase II to IV studies.
* Visits to include monitoring of proper informed consent procedures, compliance with protocol in accordance with GCP/ICH Guidelines and other applicable regulatory requirements.
* Detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.
* Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
* Report to project team, client, and site personnel any findings noted at monitoring visits followed by completion of monitoring reports and follow-up letters within the project-specific timelines.
* Maintain project tracking system of subject and site information.
* Participate in company-required training programs.
* Perform other duties as assigned by the management.

Qualification/Requirements:
* Minimum 2 years post-degree experience in Clinical Research (GCP Trained).
* Graduates/PG in life sciences, B.Pharm, M.Pharm, M.B.B.S or PhD qualification or equivalent.
* Proficient in use of MS Office (Word, Excel and Access)
* Willingness to travel- regional, national and international including overnight stays

If you have relevant experience and would like to be part of ClinTech Research family, please send your resume to career@clintechresearch.com for further consideration.

About us :
ClinTech Research is a service company focused on preclinical development, founded in 2005 as a New Jersey, USA company with a subsidiary in India.The Leadership Team of ClinTech Research is led by Sri P Srivastava, PhD, Founder & CEO who has technical experience related to the full range of pharmaceutical R&D activities.

Contact us :
CLINTECH RESEARCH India Pvt. Ltd.
Biotechnology Park,
Sector - G, Jankipuram
Lucknow, UP 226021, INDIA
Tel. : +91 (522) 4045207
http://www.clintechresearch.com

[Guest]

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[Guest]

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[Guest]

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[jyotshna reddy]

This is Jyotshna I Have completed my Bpharmacy and now i'm pursuing PGDiploma in clinical research, clinical data management,regulatory affairs. I am having interest to these jobs.
My resume :
JYOTSHNA.V
E-Mail : vemulajyotshna AT gmail.com
OBJECTIVE :
Looking for a position that offers me an opportunity for a advancement in my career, where I can utilize my skills, Knowledge to complete the tasks which are delegated to me within the time and work hard to attain success to my company.
CURRENTLY DOING :
Now I am pursuing P.G.Diploma in clinical research associate program (CRA) and data management (SAS, ORACLE CLINICAL) from Clinwell Kriger training and research institute (CKTRI), Agra, which is in collaboration with Clinwell research inc., USA and Kriger research center (KRC), USA.

ACADAMIC PROFILE :
Course Name of the Institution Board/ University % Year
B.Pharmacy Ragavendra institute of Pharmaceutical research institute. J.N.T.University,
Anantapur. 72.62 2010
XII
Sri Sai Jr college, Anantapur. Board of
Intermediate 80% 2006
S.S.C Sri Balaji Vidyaniketan,
Anantapur. Board of Secondary Education 80% 2004
SKILLS :
- Handy Knowledge of Clinical Trail process.
- Detailed knowledge of ICH-GCP and schedule-Y guidelines.
- Detailed knowledge of regulatory requirements.
- Detailed Knowledge of Drug development process.
- Detailed knowledge of Regulatory Affairs.
COMPUTER SKILLS :
- Internet concepts, Hardware and Networking.
- Ms-Word, Ms-Excel and Power point.
INSTRUMENTS HANDLED :
HPLC, U.V. visible spectrophotometer, column chromatography.
INDUSTRIAL TRAINING :

Undergone training for 30 days (16th May 2009-15th June 2009) and worked in Quality control and production in the tablet section and gained knowledge about industry in ENDOVEN Pharmaceuticals.
PROJECT WORK :
- Preparation and Evaluation of controlled release matrix tables of venlafaxine HCL by using HPMC and Sod.CMC.
- Practical knowledge of EC Dossier[Ethics committee submission for approval]
- Site Assessment Analysis.

[Guest]

MR. FIROJ HOSSAIN GHARAMI

Email-bappag AT yahoo.com
2. PROFESSIONAL OBJECTIVE
To work in a challenging and dynamic working environment and to add value to the organization, which I represent and serve, and also to myself, while concurrently upgrading attitude, skills and knowledge.
3. PROFESSIONAL AND ACADEMIC QUUALIFICATION
Degree / Exam Board/ University Year
PG in Clinical Research Excellence Norton Training Institution (UK) 2009
PG in Computer Hardware/Software Engineering The George Telegraph College (Kolkata) 2007
FA & DTP Infotech, Delhi 2007
B.COM (P) C.U 2003
Higher Secondary W.B.C.H.S.E 2000
4. OTHER ACCADEMIC ACHIVEMENTS
- Certificate in PGD in Clinical Research from Norton Training Institute
(United Kingdom).
- Certificate in Computer Hardware Engineering & Networking/ Software from
George Telegraph Training Institution.
- Certificate in D.T.P from INFOTECH (Delhi) in 2007
- Certificate in Financial Accounting (F.A). (Tally7.2) from INFOTECH (Delhi)
in 2007
- Disaster Management Training Certificate (Govt. of West Bengal).
- Certificate in Computer Hardware & UPS Training in ELECTRONICS
RIGIONAL TEST LABOTORY (ERTL). [Govt. of India].
5. COMPUTER PROFICIENCY
- Well conversant with Windows, MS Office, Excel, Power Point and Internet operation, C Language.
6. BRIEF DESCRIPTION OF WORK
- Currently working as Sr. Clinical Research Coordinator & Data Manager in Clinical
Trail Department under Dr. Ashis Mukhopadhyay, Dr. Ritwik Pandey, Dr. Chinmay
Bose.
- Data Management in e-CRF through Internet (Oracle Clinical Remote Data Capture
(OC-RDC 4.6 UPGRADE ( eDM 3.3 Outage) ] & In Form data captured Software).
- Coordinate in Indian Council of Medical Registry (CTRI) at NICED,
Kolkata.
- Pivotal coordinator for Glivec International Patients Assist Programme (GIPAP) for
my institute NCRI under chief physician Dr. Ashis Mukhopadhyay. (Conducted by
NOVARTIS, Basel, Switzerland).
7. Central Drug Standard Control Organization (DCGI) Inspections faced
- On dated 20th Jan & 21st Jan 2011 GCP Inspection by CDSCO at Netaji Subhash Chandra Bose Cancer Research Institute, Kolkata of the Clinical Trial entitle “ A multinational, randomized, double blind placebo control study to evaluate the efficacy and safety of AVE 5026 in the prevention of Venus Thromboembolism (VTE) in cancer patients at high risk for VTE who are undergoing Chemotherapy. (Protocol EFC 6521).
8. CLINICAL TRIALS WORK EXPERIENCE
Period : Since June 5th 2006 to till now.
Designation : Sr. Clinical Research Coordinator (CRC) & Data Manager (CDM).
Employer : Netaji Subhash Chandra Bose Cancer Research Institute, Kolkata-700016,
India.
Start Date Phase (I,II,III,IV) Indication Sponsor Name
14 Sep 2007 III Squamous cell Carcinoma of Head and Neck Pherma- Olam
20 Sep 2007 II Oral Mucositis Serenex /Coserex
26 Dec 2007 III Breast Cancer GlaxoSmithKline Pharmaceuticals Ltd
10 Jan 2008 I/II Multiple Myeloma Nicholas Piramal Ind. Pvt. Ltd.
4 Feb 2008 III Non Hodgkin’s lymphoma Eli- Lilly
15 May 2008 III Acute Lymphoblastic Leukemia Lambda Therapeutic Research
19 Jun 2008 IV CML Sun Pharma Pvt. Ltd
02Aug2008 II Mantle cell Lymphoma Jhonson & Jhonson Pvt.Ltd
02 Aug 2008 II VTE in Cancer Disease. Sanofi Aventis
02 Aug 2008 II Ca Breast / Prostate Merck & Co. (USA)
15 Dec 2008 I Acute Lymphoblastic Leukaemia Lambda Therapeutic Research Ltd(6 MP)
24 Feb 2009 II NHL Ranbaxy / MARC
22 Feb 2009 II NSCLC Cadila Pharmaceuticals Pvt. Ltd
03Mar2009 I Multiple Myeloma SIRO
16 Apr 2009 II Carcinoma Prostate Bristol Myers Squibb Pvt. Ltd.
25 Apr 2009 I/III HRPC Cadila Pharmaceuticals Pvt. Ltd
30-Jul-2009
04-Mar-2010
28-Mar-2010 II
II
III Advanced Solid Tumor
Idiopathic Thrombocytopenic Purpura
Thyroid Lambda Therapeutic Research Ltd
Grifols
PPD Clinical Research Pvt. Ltd
04-Jun-2010
11-July-2010
03-Sep-2010
BE
III
III ALL
NSCLC
AML Accutest Research laboratories Pvt. Ltd
Amgen 200070782
Pharma Olam International Pvt Ltd.
9. CONFERENCE ATTENTDED
- Conference attended in Indian Council of Medical Registry (CTRI) at
NICED, Kolkata, July 08.
- Conference attended Investigator Meeting by Sanofi Aventis in HONG
KONG, June 08.
- Conference attended Investigator Meeting by Eli- Lilly Company at kolkata on 29th
March 2009
- Conference attended in ICH-GCP training with Investigators Meets by Bristol Myers
Squibb company in Mumbai, 03rd & 4th April 09.
- Attended 2nd National conference on New Frontiers Of Haematology and Oncology on 9th &
10th April 2009, Swabhumi, Kolkata.
Squibb company in Mumbai, 03rd & 4th April 09.
- Conference attended in Investigator Updating Meeting by Sanofi Aventis
in Singapore on dated 8th & 9th October 2009.
- Attended National conference on Screeing & Prevention of Cancer on 7th November 2009,
Swabhumi, Kolkata.
- Conference attended in Investigator Meeting by Onconova (Max Neeman
International) at Mumbai on dated 11th & 12th December 2009.
- Conference attended in Investigator Meeting by Actavis (Lotus Labs. Pvt Ltd) at Bangalore on dated 19th & 20th December 2009.
- Attended 3nd National conference on New Frontiers Of Haematology and Oncology on 11th & 12th September 2010, Swabhumi, Kolkata.
- Attended seminar on HER2 Neu Positive Breast Cancer on 19th September 2010, ITC Sonar, Kolkata organized by Glaxo Smith Cline (GSK).
- Attended seminar on Cancer Pain & Palliative Care on 25th September 2010, Taj Bengal, Kolkata organized by Dr. Reddy’s Laboratory.
9. EXTRA CURRICULAR ACHIVEMENTS
- Certificate of Investigator Meets (IM) of Clinical Good Practice training program
Conducting clinical trial with Sanofi- Aventis dated June 2008.
- Certificate of GCP (Good Clinical Practice) by Eli- Lilly Company on 29th
March 2009.
- Certificate of Investigator Meets (IM) of Clinical Good Practice training program
conducting clinical trial by Bristol Myers Squibb Pvt ltd in Mumbai, 03rd & 4th
April 09.
- Certificate of Investigator Meets (IM) of Clinical Good Practice training program
conducting clinical trial Onconova (Max Neeman International at Mumbai on dated
11th & 12th December 2009.
- Certificate of Investigator Meets (IM) of Clinical Good Practice training program
conducting clinical trial Actavis (Lotus Labs. Pvt Ltd at Bangalore on dated 19th &
20th December 2009.
- Certificate of Completion TAO ON- SITE Training by BMS (Bristol Myers
Squibb Pvt ltd).
- Certificate of completion Monitoring Responsibilities at by BMS (Bristol Myers
Squibb Company).
- Certificate of completion of Clinical Good Practice (GCP) of the training
Program conducting clinical trial with Bristol Myers Squibb Pvt Ltd.
- Certificate of completion of Informed Consent Procedure of the training
program conducting clinical trial with Bristol Myers Squibb Pvt. Ltd..
- Certificate of completion of Adverse Event Reporting of the training
Program conducting clinical trial with Bristol Myers Squibb Pvt. Ltd.
- Certificate of completion of Study Documentation of the training program
conducting clinical trial with Bristol Myers Squibb Pvt Ltd.
- Certificate of completion of Clinical Good Practice training program
Conducting clinical trial with SIRO International Pvt Ltd.
- Certificate of completion of Norton Clinical Training Institution by Online on dated 24-Oct-09.
- Certificate of completion of Clinical Good Practice training program
conducting clinical trial with Onconova (Max Neeman International Pvt Ltd).
- Certificate of participation in 2nd National conference on New Frontiers of Haematology & Oncology on 9th & 10th April 2009, Swabhumi, Kolkata.
- Certificate of participation in 3nd National conference on New Frontiers of Haematology & Oncology on 10th & 10th Septemberl 2010, Swabhumi, Kolkata.
10. PUBLICATION
A) 8th INCTR Meeting on Cancer in Countries with Limited Resources 2009.
ABSTR ACT- 35
(INCIDENCE OF LUNG CANCER IN THE ACTIVE SMOKERS : AN EXPERIENCE FROM EASTERN INDIA. Antalya, Turkey, March 22-24, 2009).
B) 3rd National Conference New Frontiers in Hematology & Oncology, September 11, 12, 2010, Kolkata.
1) “Hyponatremia in first line therapy of advanced and locally advanced lung cancer : Indian experience”.
2) Receptor status in breast cancer reproductive history : is there any relation-
11. KEY RESPONSIBLILITIES
- Reviewing the protocol and other materials like Informed Consent Forms.
- Looking at subject eligibility requirements and determining if those subjects would be available in the site.
- Assessing the ability to meet study timelines in light of other site commitments and overall feasibility.
- Assessing the resources necessary to do the study, including people, physical space, materials etc.
- Training the other staffs involved in the trial.
- Setting up and organizing study files.
- Creating and reviewing study-specific source documents and other study-related materials.
- Disseminating information about the study to others in the institution.
- Arranging the submission of necessary documents to the IEC.
- Collecting the documents needed to initiate the study and sending them to the sponsor.
- Attending the investigator meeting.
- Clarifying any necessary items with the sponsor.
- Assisting in writing consents.
- Interacting with the sponsor on Informed Consent wording issues.
- Presenting the Informed Consent Form to potential subjects, discussing the consent and the study with them, and answering questions.
- Obtaining all the necessary signatures and dates on the Informed Consent Forms.
- Documenting, distributing and filing signed Informed Consent Forms appropriately.
- Ensuring that all amended consent forms are appropriately implemented and signed.
- Contacting and screening potential subjects for the study.
- Recruiting subjects.
- Scheduling subject and sponsor visits.
- Ensuring that all study procedures are done in each and every subject visit.
- Ensuring that all the necessary data are gathered and recorded in the appropriate source documents and the case report forms.
- Reviewing source documents and case report forms for completeness, correctness and logical sense.
- Working with sponsor monitors (CRAs) during monitoring visits.
- Resolving data queries through paper CRF & e CRF.
- Ensuring that study documents are complete, current and filed correctly.
- Maintaining study supplies accountability and reordering study supplies as necessary.
- Managing payments to study subjects.
- Completing study closeout activities at the end of the study.
- Coordinating with other departments (laboratory, pharmacy etc.) as necessary.
- Maintaining regular communications with sponsors and/or CROs, IECs and other parts of the institution.
- Ensuring adherence to ICH-GCP in conducting all the trial activities.
- Ensuring safety and well-being of all study subjects throughout the trial.
12. ADDITIONAL RESPOSIBILITIES
- Helping to recruit new studies.
- Professionally representing the site to all people / organizations in the best possible light.
- Assessing feasibility of new sites.
13. STRENGTH
- Effective Communication Skill
- Very Good Listener
- Good Memory
- Improvement facilitating attitude
- Good Patience Level
- Adaptability and Flexibility