Clinical Research Associate

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:

• Under close supervision, 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.
• Under close supervision, 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.

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, at Line Manager’s discretion.
• 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 with experienced CRAs, 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.
• All the functions listed above are closely supervised by the Line Manager or delegated.

Education Required:

• BS in a scientific or healthcare discipline

Computer Skills:

• Efficient in Microsoft Word, Excel, PowerPoint, Outlook and use of a laptop computer and iPhone.

Other Qualifications:

• 1+ years of experience in oncology/onco-hematology trials
• Good knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and associated regulatory guidelines.
• Monitoring experience in the pharmaceutical or CRO industry preferred
• 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
• Good 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 and German.
  

Travel: up to 60%

Salary Range Switzerland: 92,200.00 CHF - 115,200.00 CHF

Salary Range Germany: 50,100.00 EUR - 62,600.00 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