Clinical Outcomes Associate

http://www.shine.com/jobs/clinical-outcomes-associate/icon-clinical-research-india-private-limited/1304810/?utm_source=Indeed&utm_medium=organic&utm_campaign=Indeed#

Icon Clinical Research India Private Limited.

Posted on 13-Sep-2013

• Location(s)more
• Experience2 to 5 Yrs

IndustryPharma / Biotech

Ensures timely collection of documents and components of Adjudication Packages for Clinical Endpoint Committees to allow quality and complete adjudication of potential clinical endpoints occurring in clinical trials.
Collect, QC and ensure that the package content is medically complete and appropriate to allow physician adjudicators the ability to apply objective endpoint definitions to each case presented to them. 
Must have knowledge of and adherence to all applicable aspects of Good Clinical Practices, Federal Regulations, International standards and company SOPs is required.
Will construct medically complete and logical adjudication dossiers for presentation to physician adjudicators.
Also responses to queries from Physician adjudicators, Clinical Site Personnel, Company Personnel as it relates to collection of dossier components. 
Will be responsible for, in collaboration with project management, generating status and progress reports for committees and tracking performance and quality among adjudicators. They will also work with Project Management and Clinical Operations to generate all necessary committee documentation, preparing periodic reports and reviews of certain cases, identify potential sources of un-blinding, extract Endpoint/AE data from various source documents and spontaneous sources. 
Manages case-related information including interpretation of medical conditions, lab results, and procedures as well as compile complete narrative summaries and ensure proper coding (MedDRA) into the Clinical Endpoint Committee database. 

Role Requirements / Skills / Experience Required : 


RN is required along with two or more years of relevant work experience in drug development or clinical industry.
Excellent critical thinking skills
Data Management experience is a plus
Experience working with FDA regulations and reporting requirements and experience working with the MedDRA dictionary is preferred.
Experience working with electronic data (eCRFs), Microsoft Office Applications and other electronic data capture and transfer methods is highly desirable.
Excellent verbal and written communication skills. Must be detailed oriented and possess excellent organizational skills.
Willingness to travel 10%.

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