Opening For Clinical Research Associate - Södertälje, Sweden

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Amar Annamalai
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Opening For Clinical Research Associate - Södertälje, Sweden

 AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives – and are made to feel valued, energized and rewarded for their ideas and creativity.
 
Site Management & Monitoring (SM&M) is the Research & Development (R&D) function that executes and delivers clinical studies (phase II – IV). The local SM&M function is placed at the Astra Zeneca Nordic-Baltic Marketing Company, we seek diversity in the work place. The Clinical Research Associate has local responsibility for the delivery of studies allocated to the sites and is an active participant in the local study teams. Our studies run in the Nordic-Baltic countries and you are required to be able to travel within this area, and the position is based in Södertälje, Sweden.
 
The role
 
The CRA is responsible for the preparation, initiation, monitoring and closure of an agreed number of sites in clinical studies according to AZ procedural documents, international guidelines such as ICH-GCP as well as local regulations and delivery according to the commitment in the individual trials.
 
Main accountabilities/Responsibilities
 
Contribute to the selection of potential investigators/sites
Train, support and advise investigators and site staff in study related matters
Initiate, monitor and close study sites in compliance with AZ procedural documents
Drive performance at the sites. Proactively identify study-related issues and escalate as appropriate
Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at sites.
Perform source data verification according to SDV plan
Provide monitoring visit reports within required timelines
Ensure accurate and timely reporting of Serious Adverse Events by the site
Work with Data Management to ensure high quality of the study data
Prepare for activities associated with audits and regulatory inspections in liaison with local Study Delivery Team Lead and CA & A
Actively participate in local team meetings
Contribute to national investigators meetings
Actively share applicable information that is relevant to Sales & Marketing and Medical Department in accordance with Corporate Ethical guidelines
Ensure compliance with AstraZeneca’s Code of Conduct and company policies
Minimum requirements
 
Minimum university degree and/or equivalent, preferred in biological science or healthcare related field
At least 2 years experience as a CRA
Fluently spoken and written English and Swedish, in addition, if any other of the Nordic languages are fluently spoken and written it will be considered a merit.
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Good knowledge of relevant local regulations
Good medical knowledge in relevant AZ therapeutic areas
Basic understanding of the drug development process
Good understanding of clinical study management including monitoring, study drug handling and data management
Very good communication skills
Ability to travel nationally as required
Drivers license
More information
 
For more information about the position please contact: Kia Bengtsson, Clinical Research Manager, CRA/SDA line manager, Site Management & Monitoring Nordic-Baltic, Phone +46 8 552 522 37.
 
Welcome with your application no later than November 9, 2014.
 
Interviews will be held ongoing during the application period