Senior Clinical Research Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/781utp

ph3General Description: /h3pBeOne 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. /ppCRA executes clinical monitoring activities at clinical trial sites and monitors clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs. /ppCRA performs monitoring activities related to selection, initiation, conduct (recruitment, quality data collection) and timely completion of oncology/onco-hematology clinical trials within the assigned country/region. /ppMay be assigned to CRA activities or start-up activities, depending on experience and project needs. /ppCRA is responsible for collaborating closely with the Country and Regional Clinical Study Teams to ensure study timelines are adhered to and required quality standards are maintained. /ppCRA identifies gaps and areas for improvement and propose CAPA. /ppCRA supports start-up and provides local expertise. expertise. /ph3Essential Functions of the job: /h3ulliComplete appropriate therapeutic, protocol and clinical research training/CRA training to perform job duties. /liliGain experience in BeOne and study procedures by working with experienced clinical staff. /liliPerform site selection and evaluation, supporting initial list of sites and recruitment targets. /liliProvide protocol and related study training to assigned sites. /liliConduct onsite/remote pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs. /liliConduct co-monitoring visits, if required. /liliCreate and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports,



generating follow-up letters and other required study documentation, in accordance with ICH-GCP, BeOne standards and SOPs. /liliManage sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution /liliEnsure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements. /liliEnsure inspection readiness of the study and sites /liliEstablish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations. /liliCollaborate with Country and Regional Clinical Study Managers and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.) /liliFacilitate Study Compliance Visits (SCVs), site audits and/or inspections, as required /liliEvaluate the quality and integrity of site practices - escalating quality and/or GCP issues with Investigators and internal team as appropriate. /liliAnticipate 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.



/liliMentor junior staff (Associate CRA and CRA). /liliAct as the escalation point person for CRA(s) with site-related issues and concerns. /liliMay review visits reports, following-up on issue resolution and communicating with the Country/Regional Clinical Study Manager on significant risk identified and action proposed. /liliMay serve as subject matter expert for clinical operations, country regulations and monitoring-related activities. /li /ulh3Supervisory Responsibilities: /h3ulliMentor/Buddy for junior CRAs. /liliActs as the escalation point person for CRAs with site-related issues and concerns. /liliMay serve as subject matter expert for clinical operations and CRA-related activities; /li /ulh3Education Required: /h3pBS in a scientific or healthcare discipline preferred and at least 3 - 5 years of monitoring experience. /ppExperience in oncology/onco-hematology global trials preferred /ph3Other Qualifications: /h3ulliAdvanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and associated regulatory guidelines. /liliAt least 3 - 5 years of (CRA) monitoring experience in the pharmaceutical or CRO industry. An equivalent combination of education, training, and experience may be considered. /liliExperience in oncology/onco-hematology trials preferred /liliExcellent communication and interpersonal skills /liliAbility to establish and maintain effective working relationships with coworkers, managers, and other internal/external stakeholders as applicable /liliExcellent organizational and problem-solving skills and ability to prioritize and multitask /liliEffective time management skills /liliWritten and verbal communication skills, including a good command of the English l /li /ul /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/781utp