Clinical Research Associate (CRA) II - sponsor-dedicated in Bucuresti

Clinical Research Associate (CRA) II - sponsor-dedicatedLocation: Bucharest, Romania / Home Office, Romania In this role, you will work directly with one of our renowned key sponsors, supporting them and your assigned study sites during phase I - III of clinical trials. You will have a direct impact on the development of innovative medications, improving the lives and health of patients every day. If you are looking to broaden your therapeutic expertise whilst gaining exposure within a world class pharmaceutical working environment, this is an excellent opportunity! What we have to offer: flexible working hours, capped overtime and compensatory time off in lieu100% home-based, permanent employment contracttravel time = work timehighly competitive compensation packagesregular, merit-based salary adjustmentslunch allowances on work daysextensive medical coverance under our insurance planexcellent training and career development opportunites as well as support with furthering your educationstrong support from Line Management and more than 20'000 colleagues worldwidethe world's most renowned pharmaceutical companies as our satisfied, repeat customers for many years Your main responsibilities:Perform required monitoring tasks at your study sites in an efficient manner, according to SOPs and established guidelines; prepare accurate and timely trip reports and own all aspects of study site management as described in the project plansEnsure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the studyProtect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by diligently reviewing source documents and monitoring the data for missing or implausible entriesGenerate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systemsAct as a central point of contact for clinical trial suppliers and other vendors supporting your studiesOwn the entire process of Serious Adverse Event (SAE) reporting pertaining to your studiesDegree in a relevant field such as life sciences, (veterinary) medicine, pharmacology, biology, chemistry, health care, health management, nursing, oecotrophology etc.,In lieu of the above, a completed vocational education in a relevant field (e.g. nursing) or equivalent professional experience in clinical research (e.g. as a study coordinator)Professional independentg site monitoring experience as a Clinical Research AssociateExperience in one or more of these therapeutic areas: diabetes, cardiovascular, inflammatory diseases, oncologyFamiliarity with applicable Romanian and international regulatory requirements such as GCP / ICHWorking knowledge of Microsoft Word, Excel and PowerPointEffective time management and organizational skills and a keen attention to detailAbility to establish and maintain effective, trustful working relationships with diverse internal and external stakeholdersBusiness fluency in Romanian - both spoken and written - as well as a good command of English are a must Remote#LI-AR12021-08-06 16:08:59