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Job Description

Job Description
Quintiles (NYSE: Q) is theworld’s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 29,000 employees conducting business in approximately 100 countries. We helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market.

Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more abou tQuintiles, please visit www.quintiles.com

PURPOSE
Provide administrative support to clinical projects under direction of line manager, Clinical Research Specialist and/or other designated clinical team members. Assists with general administrative functions as required.
RESPONSIBILITIES Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) 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 completeness.
 Assist CRS/iCRS, CRAs/iCRAs and RSU 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 accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
 May perform assigned administrative tasks to support team members with clinical trial execution.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
 Awareness of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
 Knowledge of applicable protocol requirements as provided in company training
 Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
 Good written and verbal communication skills including good command of English language
 Effective time management and organizational skills
 Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE High or Secondary School diploma/certificate or country’s educational equivalent and 3 years administrative support experience; or equivalent combination of education, training and experience


About Quintiles

Quintiles helps biopharma and other healthcare companies improve their probability of success by connecting insights from our deep scientific, therapeutic and analytics expertise with superior delivery for better outcomes. From advisory through operations, Quintiles is the world’s largest provider of product development and integrated healthcare services, including commercial and observational solutions.Conducting operations in approximately 100 countries, Quintiles is a member of the FORTUNE 500 and has been named to FORTUNE’s list of the “World’s Most Admired Companies.” To learn more, visit www.quintiles.com
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