Clinical Research Associate

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8ks64x

BeOne 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.
General Description: 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.
CRA 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.
May be assigned to CRA activities or start-up activities, depending on experience and project needs.
CRA 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.
CRA identifies gaps and areas for improvement and propose CAPA.
CRA supports start-up and provides local expertise.
Essential Functions of the job: Complete appropriate therapeutic, protocol and clinical research training/CRA training to perform job duties.
Gain experience in BeOne and study procedures by working with experienced clinical staff.
Perform site selection and evaluation, supporting initial list of sites and recruitment targets.
Provide protocol and related study training to assigned sites.
Conduct onsite/remote pre-study, initiation, routine monitoring and closeout visits per monitoring plan and applicable SOPs.
Conduct co-monitoring visits, if required.




Create 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.
Manage sites and site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
Ensure 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.
Ensure inspection readiness of the study and sites Establish regular lines of communication with sites and reports site progress, issues and proposed action to Clinical Operations.
Collaborate 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.) Facilitate Study Compliance Visits (SCVs), site audits and/or inspections, as required Evaluate the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriate.




Anticipate 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.
Computer Skills: Efficient in Microsoft Word, Excel, PowerPoint, Outlook and use of a laptop computer and iPhone.
Other Qualifications: Proficient knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines and associated regulatory guidelines.
At least 2 years of (CRA) monitoring experience in the pharmaceutical or CRO industry Experience in oncology/onco-hematology trials preferred Excellent communication and interpersonal skills Ability to establish and maintain effective working relationships with coworkers, managers and other internal/external stakeholders as applicable Excellent organizational and problem-solving skills and ability to prioritize and multi-task Effective time management skills Written and verbal communication skills including good command of English language.
Travel: up to 60 % Salary Range EU: 40,****** EUR - 50,****** EUR Global Competencies 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.
Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8ks64x