Closing Date: 31 Jan 17
Type: Full Time
Salary (£): Competitive
Please revert to the job description.
Chiltern is Europe’s largest privately owned full service (Phase I-IV) Clinical Research Organization, with 4,200 employees and offices throughout Europe, both Eastern and Western, North and South America and Asia. We listen to client needs to deliver customized clinical development solutions with a team working across 47 countries to provide comprehensive, yet flexible and responsive, services. Our specialties include Clinical Development, Oncology, Devices and Diagnostics, Data, Analytics & Evaluation and Strategic Service Provision.
Chiltern is looking to recruit an experienced monitor based in Sweden to work in the role of Clinical Research Associate II (CRA II) or Senior Clinical Research Associate (SCRA). This role offers excellent exposure to all therapeutic indication types and a defined career development.
The CRA is a high-profile role within the department, using their experience as a ‘knowledge resource’ to help other CRAs develop their skills.
The CRA will provide expert advice, guidance and general supervision to Clinical Monitoring team activities for designated projects, and to monitor specified sites to ensure quality and integrity of data, ensuring study completion on time and within budget. They may be called upon to interact independently with clients not directly involved in their projects, and to assist in some relevant departmental tasks.
We encourage the development of CRAs into the lead function giving co lead responsibilities where possible and excellent exposure. We also welcome applicants that want to be career monitors.
Job Primary Functions:
• The successful applicant will be responsible for coordinating Phase I-IV clinical trials in Europe
• Perform all types of site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and termination visits.
• Assist with document submissions to local authorities
• To identify potential sites for a proposed study in conjunction with the Project Team, and conduct feasibility assessment of sites as required
• Ensure that all study related communication including e-mail is tracked, printed and filed as required
• To track patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and LCRA
• To liaise with all other appropriate departments within Chiltern International to ensure the smooth running of the study
• To assemble files and ensure documents for the trial master file accurately reflect the progress of the study
• Other Ad-Hoc CRA duties
• A BSc or BA degree in a biomedical or related life science, or nursing qualification
• Previous CRA experience within clinical research of approximately 24 months
• Good clinical knowledge with an understanding of medical terminology
• An understanding of the basics of physiology and pharmacology
• Understanding of the principles of ICH GCP and regulatory requirements
• Experience using a clinical trial management system
• Preferable experience using a clinical trial management system (CPMS)
• Experience as a CRA on single site and/or multicentre trials
• Good oral and written communication, organizational skills and personal presentation
• The ability to communicate effectively in English and in Swedish
• Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications
The successful candidate will have well rounded and recent therapeutic experience within the areas of Biopharma.
• This is a permanent, full time and home based role based Sweden
• National and international travel availability is required (monitoring in the Denmark and the Netherlands)
• May also involve travel to meetings or attendance at conferences
• Overnight stays may be required
• No freelance applications or agency enquiries will be considered
• Please submit your CV and a detailed covering letter explaining why you are suitable candidate. If you do not submit a covering letter this may affect your application
Please send your CV to firstname.lastname@example.org
For more information about Chiltern International, please visit our web site at www.chiltern.com
Successful candidates will have the opportunity to be part of a growing company with a strong brand and professional employees that care about the work they are involved in. Chiltern is constantly working to develop training capacity, therapeutic expertise, new technologies and processes to be one of the leading CROs globally.
Working for Chiltern will offer an excellent opportunity to raise your profile and develop your career whilst giving you the flexibility to enjoy a good work life balance.
Please note that if your experience does not mirror that of our requirements for this role you may not receive a response.
Norsk-Data-Strasse 1, 61352 Bad Homburg v.d.H. Germany
|Tel:||+49 6172 9443 0|
|Fax:||+49 6172 9443 300|
|Website:||Visit Our Web Site|
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