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

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

PharmaNet

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.

 This Job is posted in http://www.pharmanet.com/aboutus/html/ for more details visit https://www.ultirecruit.com/pha1001/JobBoard/SearchJobs.aspx?__SVRTRID=B83DF025-78B0-457B-8A55-E71AF5DA1A6C

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
Advertisements

Make a Comment

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Liked it here?
Why not try sites on the blogroll...

%d bloggers like this: