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Sunday, 6 April 2014

Clinical Trials Assistant-1314261 @ Quintiles - Bangalore "D"

Description

 
Provide administrative support to clinical projects under direction of line manager, Clinical Team Leads and/or other
designated clinical team members. May assist with general administrative functions as required.

RESPONSIBILITIES
• Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining
clinical systems that track site compliance and performance within project timelines.
• Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for
accuracy and completeness.
• Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated
documentation.
• May perform assigned administrative tasks to support team members with clinical trial execution.
All responsibilities are essential job functions unless noted as nonessential (N).

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Awareness of knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and
International Conference on Harmonisation (ICH) guidelines
• Knowledge of applicable protocol requirements as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
• Strong written and verbal communication skills including good command of English language
• Effective time management and organizational skills
• Attention to detail and accuracy in work
• Ability to establish and maintain effective working relationships with coworkers, managers and clients

PHYSICAL REQUIREMENTS
• Extensive use of telephone and face-to-face interactions, which require accurate perception of speech
• Extensive keyboarding involving repetitive motions with fingers
• Regular sitting for extended periods of time
• Packaging and lifting supplies for storage and shipping
• Occasional travel

Qualifications

 
 School diploma/certificate or educational equivalent; or equivalent combination of education, training and experience




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