Clinical Research Associate II – 2 Years Experience – PharmaNet, Bangalore

Posted on December 24, 2008. Filed under: Pharmaceutical | Tags: , , , , |


PharmaNet, a global, drug development services company, provides a comprehensive range of services to the pharmaceutical, biotechnology, generic drug, and medical device industries. PharmaNet offers clinical-development solutions including consulting services, Phase I clinical studies, bioequivalency and pharmacodynamic studies, bioanalytical analyses, and Phase II, III, and IV clinical development programs. In addition, PharmaNet offers technology tools for managing clinical trial data.

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Job Details

Requisition Number 378
Post Date 12/3/2008
Title Clinical Research Associate II
City Bangalore
Country India
Description Job Functions:
• Monitor (pre-study, initiation, routine, and close-out visits) at investigator sites (40 – 50% travel) for GCP compliance according to PharmaNet SOPs and/or client guidelines
• Recruit investigators for participation in clinical trials
• Negotiate study budgets with investigators
• Obtain, review for appropriateness, and process regulatory and administrative documents from investigator sites
• Review draft protocols for completeness and feasibility
• Develop Case Report Forms for clinical trials
• Present (e.g. study specific guidelines and procedures, case report forms, and monitoring conventions) at Investigators’ Meetings
• Prepare and process Serious Adverse Event (SAE) reports
• Prepare project management reports for clients, project personnel, and PharmaNet management
• Review and verify CRFs and other clinical data, in-house, for completeness and accuracy; generate queries
• Resolve queries of CRF data with study site personnel
• Review Tables and Listings generated from study data
• Assist in writing Clinical Study Reports
• Train junior CRAs on monitoring, internal procedures, and query resolution
• When allocated by study management, submit essential/required documents to a central IRB or a country’s central Ethics Committee, and, if necessary based on local requirements, the Competent Authority
Requirements Minimum Requirements:
• Bachelor’s Degree or RN
• Two years’ work experience in clinical research, data management, regulatory affairs, or other relevant healthcare research position
• Eighteen months’ experience in field monitoring of clinical trials. Alternatively, twelve months’ experience in field monitoring of clinical trials, plus at least one of the following qualifications:
1. Twelve months’ prior experience as a clinical study coordinator
2. Relevant post-graduate doctoral degree (e.g., PharmD, PhD, MD)
3. Five years of relevant work experience as a nurse or pharmacist
• Excellent written and verbal communications skills
• Ability and willingness to travel up to 50%
• Excellent organizational skills and ability to manage time and work independently
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