PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world. Headquartered near Boston, Massachusetts, PAREXEL operates in more than 50 countries around the world.
Post: Senior Clinical Research Associate
Job Description
Perform the clinical monitoring aspect of designated projects in accordance with study specific procedures, applicable SOPs, and regulations. Act as PAREXEL’s direct contact with assigned clinical sites and use judgment to assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites. Responsibilities include, but are not limited to applying expertise and independent judgment to independently verifying patient safety and patient rights, performing clinical on-site monitoring activities (drive patient recruitment, source data verification, drug accountability, and data collection), collecting regulatory documentation (when required), ensuring timely and high quality data, and performing qualification, initiation, monitoring, and termination of investigational sites in accordance with ICH GCP guidelines.
Candiate Profile
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4+ years of onsite monitoring experience.
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Strong ability to make appropriate decisions in ambiguous situations
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Ability to work independently and to proactively seek guidance when necessary
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Excellent presentation skills
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Client focused approach to work
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Ability to interact professionally within a client organization
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A flexible attitude with respect to work assignments and new learning
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Ability to prioritize multiple tasks and achieve project timelines, utilizing strong analytical skills to make decisions autonomously due to the unpredictable nature of the issues that arise
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Willingness to work in a matrix environment and to value the importance of teamwork
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Strong computer including but not limited to the knowledge of Clinical Trial Management Systems (CTMS), Electronic Document Management System (EDMS), EDC, IWRS, and MS-Office products such as Excel and Word
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Excellent interpersonal, verbal, and written communication skills
Additional Information:
Location: Karnataka- Bangalore
Functional Area: CR
Requisition: pare-10032836
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 25th May, 2014
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