Company: PRA Health Sciences
Closing Date: 18 Nov 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary and Benefits
An outstanding opportunity to join one of the world’s leading contract research organisations and be part of a dynamic and growing international company. Join PRA Health Sciences as a Clinical Research Associate (CRA) and help realize your career potential.
CLINICAL RESEARCH ASSOCIATE (CRA)
Location: Stockholm, Sweden
As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.
At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.
At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.
For more information please see our website: www.prahs.com
Working fully outsourced to and based at the offices of our global pharmaceutical client, the Clinical Research Associate is ultimately responsible for the successful management of investigator sites throughout the site lifecycle, whilst working in accordance with ICH-GCP guidelines, the study protocol, applicable local and international regulatory requirements and internal Standard Operating Procedures.
With full ownership of investigator sites for assigned studies, the Clinical Research Associate’s (CRA) involvement begFins at site feasibility stage, with responsibility for the successful management of the site right through to close-out. In addition to planning and conducting various site visits (feasibility, site selection, interim and close-out) in accordance with the clinical monitoring plan, the Clinical Research Associate (CRA) fosters effective relationships with investigator site staff to ensure that key clinical metrics are met. This involves establishing innovative ways of increasing site and patient recruitment. When issues do occur, the Clinical Research Associate proactively and promptly implements corrective action plans, and, when applicable, escalates issues to more senior members of the study team. The Clinical Research Associate may also design and deliver training to site staff, when appropriate.
Typical duties for a Clinical Research Associate will likely include preparing for and attending investigator meetings, coordinating the timely shipment and the subsequent proper storage and accountability of clinical supplies and following-up of drug safety issues that have occurred at site. The Clinical Research Associate (CRA) ensures integrity of clinical data through an ability to sufficiently maintain site tracking records and work diligently to relevant guidelines.
Operating as a key part of a global study team, the CRA plays a fundamental role in our client’s drug development process.
Desired skills and qualifications:
A minimum of a BA/BS degree is required, preferably in a health or science related field. Specific therapeutic area experience may be required depending on the position.Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.Willingness to travel with occasional overnight stay away from home. Proficient in speaking and writing Swedish and English Good written and oral communication skills.
To apply for this position please contact recruitment at email@example.com or call on +44 1189518505.
Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
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