Clinical Research Associate (Job # 1263)

Position Information
Posted Date	2008-12-04 16:55:32
Type	Direct-Hire
Job Category:	Clinical Research
Position	Full Time
City	Bedminster
Location	New Jersey, United States of America
Experience	Bachelor’s degree or diploma in nursing or science or medical, medical/technical, pharmaceutical, scientific or laboratory training
Education	Bachelor's Degree
Travel	30%

Description

The main responsibilities of the CRA include:  Development of study specific documentation Monitoring and/or co-monitoring of the study Recruitment tracking and supervision of study sites Training of study personnel at investigator’s sites Coordinating the approval process for the performance of clinical studies/notification to IRBs and authorities with regard to the respective study site Tracking and assurance of data quality at the site Site documentation at the investigator and in-house Organization and performance of investigator meetings Assisting with the site selection process Assessing the suitability of facilities at study centre The following description documents specific process-related tasks for which the CRA is accountable or responsible, and which have not been covered in the profile of the Study Team. In the process “Close study and archive documents” the CRA is responsible to Prepare and maintain central files Compile study-relevant documents incl. CRFs and code envelopes Initiate the archiving of the Trial Master File (TMF) In the process “Co-monitor sites” the CRA is accountable and responsible to Plan and perform co-monitoring, and write co-monitoring report Decide whether any issues have occurred and provide feedback Follow-up and ensure that all global and local issues have been solved

Qualification

Education Detail

Bachelor’s degree or diploma in nursing or science or medical, medical/technical, pharmaceutical, scientific or laboratory training Junior CRAs: less than 4-5years monitoring experience Senior CRAs: 4-5 years monitoring experience Any foreign language is an asset.

Knowledge

Industry-specific knowledge Understanding of drug development process over different phases Understanding of global regulations and guidelines  Personal skills & abilities Organize work in a structured fashion with attention to detail and compatible with other activities in the clinical project and / or  study Strong communication skills Ability to work in a team setting International and intercultural work experience