CRA II - FSP, Romania in Bucuresti

As a (S)CRA in our Flexible Solutions department, you play a central role in the success of clinical trials (phases II and III) in Romania. In this role, you will work directly with one of our renowned key sponsors, and advance the development of innovative, life-changing medications - improving thousands of patients' health and lives every day. If you are looking to broaden your therapeutic expertise and take your career as a CRA to the next level, whilst gaining exposure within a world-class pharmaceutical working environment, this is an excellent opportunity!What you can expect from us:rewarding work in a stable, successful, diverse and respected companyhighly competitive compensation packages, including local special payments and a monthly car allowancea genuine work life balanceflexible working hours and compensatory time off in lieutravel time = work timea thorough onboarding with support from your personal mentor100% home-based employment contract with Labcorp Drug Developmentemployer contributions to a highly attractive pension schemeexcellent training and career development opportunities, as well as support with advancing your educationcontinuous, individualized support from your Line Manager, your team and more than 20'000 Drug Development colleagues worldwideYour responsibilities:own all aspects of site management, from site selection to close-outensure patients' safety throughout the trial, working closely with the staff at your study sites and managing all required ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible entriesreview progress of projects and initiate appropriate actions to achieve target objectivesown the entire process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow ups on SAEsindependently perform CRF reviewsgenerate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems assist with training, mentoring and development of new employees, e.g. co-monitoringYour profile:degree in a relevant field such as life sciences, biology, health care (management), nursing, pharmacology, (veterinarian) medicine, chemistry, biochemistry, nursing, etc. in lieu of the above, a completed equivalent vocational education (e.g. study nurse, research nurse, study coordinator...) and/or equivalent professional experienceindependent site monitoring experience in Romania - preferably within a CRO or a pharmaceutical companyfamiliar with local and international regulations such as GCP / ICH as well as the Romanian regulatory authorities landscapeconfident user of software applications such as the MS Office suite and eTMFs ( Veeva Vault etc.)strong organizational skills, empathy, an autonomous work style and a keen attention to detailexcellent communication skills in business fluent Romanian and English - both spoken and written - are a mustLabcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see our .

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