Clinical Research Associate

ppBeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.br/ /ph3General Description /h3 ul liThe CRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs. /li liPerforms monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/hematology clinical trials within the assigned region. /li liThe CRA is responsible for collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained. /li liIdentify gaps and areas for improvement and propose CAPA. /li liSupports start-up and provides local expertise. /li liSSU experience is considered a plus /li /ul h3CRA activities /h3 ul liPerform feasibility, site identification, selection and evaluation, supporting initial list of sites and recruitment targets /li liProvides protocol and related study training to assigned sites. /li liConducts monitoring (pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs /li liConducts co-monitoring visits, if required /li liCompletes monitoring visit reports in accordance with ICH-GCP, BeOne Medicines standards and SOP /li liManages sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution. /li liEstablish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations /li liEnsure inspection readiness of the study and sites /li liCollaborates with Regional Clinical Operations Manager and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.) /li liAttends disease indication project specific training and general CRA training as required /li liFacilitate Study Oversight Visits (SOVs), site audits and/or inspections, as required /li liEvaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate. /li liAnticipate and identify site issues; propose corrective and preventative actions; identify gaps and utilize opportunities. Constantly strive for operating excellence, question status-quo and promote innovation. /li /ul h3Education Required /h3 ul liBS in a relevant scientific discipline and minimum of 2 years of monitoring experience. /li liExperience in oncology global trials preferred /li /ul h3Other Qualifications /h3 ul liUnderstands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines /li liAt least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industry /li liExperience in oncology/hematology trials preferred /li liExcellent communication and interpersonal skills /li liExcellent organizational skills and ability to prioritize and multi-task /li liFluent in English Italian (writing and speaking) /li /ul h3Computer Skills: /h3 Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlookbr/ h3Travel: /h3 up to 60%br/ Salary Range EU: 44,800.00 EUR - 56,000.00 EURbr/ h3Global Competencies /h3 When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.br/ ul liFosters Teamwork /li liProvides and Solicits Honest and Actionable Feedback /li liSelf-Awareness /li liActs Inclusively /li liDemonstrates Initiative /li liEntrepreneurial Mindset /li liContinuous Learning /li liEmbraces Change /li liResults-Oriented /li liAnalytical Thinking/Data Analysis /li liFinancial Excellence /li liCommunicates with Clarity /li /ul We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. /p #J-18808-Ljbffr