At Quintiles we help healthcare and biopharma companies improve their probability of success. We do this by connecting our scientific, therapeutic and analytics expertise with superior delivery. From advisory through operations, Quintiles and its affiliate companies is the world’s largest provider of product development and integrated healthcare services.
As one of FORTUNE’s ‘Most Admired Companies’ in 2016, we offer great opportunities for a career in world-leading clinical research. Our global projects, innovative tools and industry leading customers combined with outstanding support from our leadership team and clear career mapping allows you to make a difference in patient health.
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.
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
Did You Know?
* Quintiles helped develop or commercialize 98 of the Top 100 best-selling products of 2014
* Quintiles has 36,000 employees conducting business in more than 100 countries
* Quintiles was named to FORTUNE’s World’s Most Admired Companies® 2016 list
* Quintiles was named as a 2016 World’s Most Ethical Company® by the Ethisphere Institute
Primary Location: POL-Mazowieckie-Warsaw
Organization: POL02 - Poland Product Development