Clinical Research Associate (CRA)

IRW Consulting AB, a Nordic Contract Research Organisation was founded in 1999.We can offer professional clinical trial management for pharmaceutical, biotechnology and medical device companies.IRW Consulting AB has a dedicated and professional team with a wide range of talents and experience from academic and clinical medicine research, as well as experience from working with global pharmaceutical companies, biotech companies and the various Medical Product Agencies in the Nordic region.Our team can either work independently or part of your project team, pending on your request. Desirable qualifications and background .Academic degree in natural science such as life sciences .Experience from pharmaceutical, biotechnology or medical device industries .Experience from Clinical Research Organizations (CRO) .Good ability to express yourself both verbally and in writing .Good knowledge of spoken and written English .Good organizational skills .A service-minded approach .Ability to priorities and handle several tasks simultaneously .Valid driving license Principal duties .Prepare and complete applications to the regulatory authority and ethics committees .Responsible for completion of study documentation such as CRFs, patient diaries, QoL forms etc..Preparing Monitoring Manuals, Source Data Verification plans etc..Responsible for the sites and on-site management during the study process .Drug accountability .Participate in Audits and Inspections .Assist in data validation and clean file procedures .Prepare and conduct pre-study activities, selection and initiation visits, routine monitoring and closure visits .Selecting and negotiating contracts with local/central laboratories, pharmacies etc..Planning and participating at Investigators meeting .Responsible for final archiving of study documents in-house an on-site ÄR DU INTRESSERAD?Svar emotses snarast.