| CRA | |
| Kendle International Prague, Czech Republic Ref: EP141-01 |
|
The RoleThe RoleCompletes project activities associated with monitoring functions of Phase I-IV clinical research studies while developing an understanding of the drug development process, Good Clinical Practices, and relevant regulations. Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs). |
RequirementsRequirementsEducation: AA, RN, BS/BA or equivalent or experience as follows: The candidate should have at least 1.5 year or equivalent of clinical research monitoring experience; or at least one year or equivalent experience performing relevant project support in-house functions; or 1-2 years or equivalent of experience in a related health care or clinical research work experience (e.g. study coordinator). Previous practical experience in conducting clinical pharmaceutical research studies in a hospital setting, pharmaceutical company, or CRO preferred but not required. Experience or education indicates a sound basic knowledge of medical and pharmaceutical terminology. Position requires: Excellent verbal and written communication skills along with excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills. Good command of written and spoken English language. Ability to travel domestically and internationally as required and process visit reports and expense reports effectively. If applicable ability to obtain credit cards for the purpose of paying expenses while traveling. Ability to work independently. Proficient in the use of laptop computer and software systems. Ability to understand basic and complex medical details. Understanding of basic data processing functions preferred. Knowledge of GCP and all applicable regulatory requirements preferred. |
About the CompanyAbout the CompanyKendle is a leading global clinical research organization providing the full range of early– to late–stage clinical development services for the world's biopharmaceutical industry. Our focus is on innovative solutions which reduce cycle times for customers Kendle was established in 1981. A founder run company, Kendle is currently ranked as the 4th largest Contract Research Organisation (CRO) for Phase II-IV studies. Employing in excess of 3,000 Associates globally, Kendle spans 6 continents with global locations across North America, Europe, Asia/Pacific, Latin America and Africa. Kendle’s Corporate Headquarters are in Cincinnati, USA and the its UK offices are in Glasgow, Edinburgh and Camberley, Surrey. We are always keen to hear from clinical professionals, particularly within the following disciplines; Clinical Trial Administrators, Clinical Research Associates, Clinical Project Managers, Regulatory Affairs Consultants/Managers, Biostatisticians, SAS Programmers, Data Managers, Pharmacovigliance professionals and Medical Writers. In June 2009 Kendle was again named among the top two providers in the 2009 CenterWatch Survey of US investigative sites, making us the only CRO to have been ranked consistently among the top two providers in the 2009, 2008 and 2007 CenterWatch Surveys of US and European Investigative Sites. Successful applications to Kendle will be rewarded with a highly competitive compensation and benefits package including; 25 days annual leave, contributory pension, private medical insurance, life assurance, permanent health insurance, Kendle College e-training & bonuses!! Car allowances will be offered for certain roles. |
....