Clinical Trials Assistant
Quintiles is searching for a Clinical Trials Assistant (CTA) for our office in Uppsala. There is a strong focus on administrative tasks in a complex clinical trial environment with large, multi-national studies for the Clinical Trials Assistants working within Clinical Operations. The preferable background is an administrative assistant from a clinical research department or a pharmaceutical company. The responsibilities of a CTA within Clinical Operations span the full duration of studies from start-up to project close-out and involve the following:
• Assist Clinical Team Lead (CTL)/Clinical Project Manager (CPM) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
• Assist with 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 with the preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist with the tracking and management of Case Report Forms, queries and clinical data flow.
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
• Act as a contact person for hospital site staff and staff from other involved departments (for example laboratory) during the course of the study.
• May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
• May manage the translation of approval letters (EC/Regulatory) and other documents as per CTL/CPM request
• General knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines preferred
• Knowledge of applicable clinical trial protocol requirements as provided in company training
• Computer skills including proficiency in use of Microsoft Word, Excel, PowerPoint and Access Database
• 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
• Diploma in Post-Secondary Education or higher or educational equivalent; or equivalent combination of education, training and experience
Please contact Helena Andersson, PhD, Quality Manager / Manager Clinical Operationson +46 (0)18 431 1217 or +46 (0)733 319 217 if you require further information.
Welcome with your application with CV and cover letter. In this recruitment we will commence interviews on an ongoing basis.
