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Home
> Doctor/Nursing Jobs |
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Senior Clinical Research Associate(Bangalore) |
| Eligibility : |
Candidate must possess at least a Bachelor of Science in Biology or equivalent. |
| Location : |
BANGALORE |
| State |
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| Designation : |
Senior Clinical Research Associate(Bangalore) |
| Details :: |
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The Company is a US $ 2 billion company. Driven by technology and innovation, The Company addresses the needs of consumers across the world with over 5,000 employees, 33 commercial locations, 4 world-class Research and Development facilities and 3 state-of-the-art manufacturing plants.The Company is committed to R & D and during the past five years has invested more than $750 million into its product pipeline. Today, that pipeline is broad and maturing, the success of which is reflected by the excellent market positions that The Company enjoys world over.In India The Company operates a joint venture .The Company also markets Lens care & surgical products under license from its parents company. We have a nation-wide distribution network of over 1100 distributors in more than 400 towns. Presently our employee strength is over 240 and our sales turnover is about Rs.100 Crores.Currently The Company is rated as one of the finest organizations to work with, both in terms of professional and personal growth. Training and development is a key focus area of the human resource policy of The Company. Currently The Company has one of the best-trained Sales and Marketing team in the health care Industry. The environment in The Company's fosters and supports a positive work ethic, transparent operations and mutual trust. Joining The Company will provide you a platform to reach your full potential and fulfill your career aspirations. The Company market share is increasing every year & has a market share of 21% currently in the ophthalmic pharma business. We are poised for further growth and dominance with massive expansion plans in India involving increased coverage and launch of exciting new products. There is a huge opportunity for people who value MNC exposure, product launches, building brands & working in a professional environment.
Responsibilities:
SITE MANAGEMENT & MONITORING OF GLOBAL CLINICAL TRIALS
Work with the investigator and their staff to ensure continuing compliance with the protocol, Good Clinical Practice (GCP), all appropriate The Company SOPs and other related documents, all national laws and regulations, and all regulatory
requirements.
Monitor the study-related documentation at the site to ensure the completeness, correctness and accuracy of the data generated - Including source documentation verification according to Company SOPs.
Identify Serious Adverse Events (SAEs) through review of source documents and report these according to Company's Standard Operating Procedures (SOPs), GCP and all regulatory requirements.Perform drug accountability and maintain adequate medication and non-medication supplies at each site as required by the trial specific protocol and monitoring plan.Undergo clinical audit and external inspections with no critical and no systematic/major findings within key areas such as monitoring oversight, consent, drug accountability, safety, and SDV and rectify all findings within the agreed time line.Maintain internal and external filing systems for allocated sites, which facilitate current and rapid retrieval of documentation and meet the requirements of GCP and Company's Clinical Research SOPs.Respect the privacy and integrity of data which the Senior Clinical Research Associate gets access to, e.g. patient names and addresses, previous and current diseases etc.ASSIST WITH THE DEVELOPMENT AND SET UP OF GLOBAL CLINICAL TRIALS.
Perform site evaluation visits with Head – Clinical Research. Assist site with preparation of human ethics and drug review committee applications.
Submit to the regulatory group all relevant documentation to obtain agency approval for clinical trial. Assist with organization of and presentation at investigators meetings. Perform site initiation visits to adequately train the investigator and their staff on the protocol content and all relevant guidelines and regulatory requirements.
ASSIST WITH DATA MANAGEMENT AND STUDY CLOSURE FOR GLOBAL CLINICAL TRIALS.
Coordinate DCFs (data clarification forms) at sites.
Perform site closure visits.
Advise the investigators in writing of their on going obligations after the study has ended.
ACT AS THE IN-HOUSE LOCAL TRAINER FOR Company SPECIFIC SOPs, TOOLS AND WIMs 10%
Would help in arranging the induction programme for all new CR recruits in collaboration with the European/Asia Pacific training group Would ensure that individual training of all CR personnel within India are in line with global standards.
Would get trained on all SOPs, tools, WIMs, Updates and train other members of the local team when required
Would help in developing local SOPs, tools & WIMs in collaboration with the Head – clinical Research
ACT AS LEAD CRA IN LOCAL TEAM FOR GLOBAL CLINICAL TRIALS
Act as point contact for the global study team in the Country. Manage the studies on a day to day basis to ensure global study milestones are met e.g. study start up, recruitment and study closure. Provide local input to global and local study–related processes and issues.
Ensure that all necessary local/country approvals are obtained and that all local/country specific study-related paperwork is available. Manage the production and collection of critical documents to ensure CSSA requirements are met in a timely fashion.
Develop study and investigator budget in consultation with the Head – Clinical Research.
Manage clinical trial agreement process in consultation with the Head – Clinical Research.
Arrange for set up of trial specific data bases.
Develop monitoring tools and tools for site such as screening logs, enrollment logs etc.
Arrange Investigator meetings
Review MVRs prior to sign off by Head – Clinical Research
Receive and disseminate information regarding site management and protocol issues through communication with the global and local study team and review of Monitoring Visit Reports (MVRs).
Identify project related training needs for local study team.
Manage all site staff study-specific training/certification requirements.
Manage study payments.
Requirements:
Candidate must possess at least a Bachelor of Science in Biology or equivalent.
At least 3 year(s) of working experience in the related field is required for this position.
Applicants should be Indian citizens or hold relevant residence status.
Preferably Senior Executives specializing in Health care - Diagnosis/Others or equivalent.
Full-Time positions available.
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| Last Date : |
2008-04-29 |
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