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    Clinical Research Associate - North Of Italy

    Beigene
    3+ years
    Not Disclosed
    Remote - Europe
    10 Aug. 14, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Clinical Research Associate (CRA) - Oncology/Hematology

    Location: BeiGene, Global (Remote with travel requirements)

    Company Overview:

    BeiGene is rapidly expanding and offers exciting opportunities for experienced professionals. We seek motivated, collaborative individuals who share our commitment to advancing cancer treatments.

    Position Summary:

    As a Clinical Research Associate (CRA) at BeiGene, you will be responsible for executing clinical monitoring activities at trial sites and ensuring compliance with ICH guidelines, GCP, local regulations, and applicable SOPs. This role involves managing the full lifecycle of oncology/hematology clinical trials within the assigned region, from site selection to trial completion.

    Key Responsibilities:

    • Clinical Monitoring:

      • Conduct pre-study, initiation, routine monitoring, and closeout visits according to monitoring plans and SOPs.
      • Perform feasibility assessments, site identification, selection, and evaluation.
      • Provide protocol and study training to assigned sites.
      • Track regulatory submissions, recruitment, CRF completion, and data query resolution.

    • Collaboration and Communication:

      • Work closely with the Regional Clinical Operations Manager to meet study timelines and quality standards.
      • Maintain regular communication with sites, reporting progress, issues, and proposed actions to Clinical Operations.
      • Facilitate Study Oversight Visits (SOVs), site audits, and inspections as needed.

    • Quality and Compliance:

      • Ensure inspection readiness of the study and sites.
      • Identify gaps and propose corrective and preventive actions.
      • Mentor and manage junior staff and other CRAs.
      • Address site-related issues and escalate significant risks as needed.

    • Documentation and Reporting:

      • Complete monitoring visit reports in accordance with ICH-GCP, BeiGene standards, and SOPs.
      • Review visit reports and follow up on issue resolution.

    Required Qualifications:

    • Education: Bachelor’s degree in a relevant scientific discipline.

    • Experience: Minimum of 3 years of CRA monitoring experience in the pharmaceutical or CRO industry, with oncology/hematology experience preferred.

    • Skills:

      • Proficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.
      • Fluent in English and Italian (both written and spoken).
      • Excellent communication, organizational, and interpersonal skills.
      • Ability to prioritize tasks and manage multiple responsibilities effectively.

    • Travel: Willingness to travel up to 60% of the time.

    Competencies:

    • Ethics: Upholds integrity and organizational values, treats others with respect.
    • Planning/Organizing: Prioritizes tasks, manages time efficiently, completes tasks on time.
    • Communication: Clearly and effectively communicates both verbally and in writing.
    • Teamwork: Contributes to team success, gives and receives feedback constructively.
    • Adaptability: Manages competing demands, adapts to changes and unexpected events.
    • Technical Skills: Pursues growth opportunities, shares expertise, and continuously builds knowledge.
    • Dependability: Takes responsibility for actions, meets commitments, and works long hours if needed.
    • Quality: Ensures accuracy, seeks improvements, and applies feedback to enhance performance.
    • Analytical: Synthesizes information, researches data, and uses experience to complement data.
    • Problem Solving: Identifies and resolves problems efficiently and skillfully.
    • Project Management: Manages projects to ensure timely and on-budget completion.

    BeiGene Global Competencies:

    • 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

    Equal Opportunity Statement:

    BeiGene is an equal opportunity employer committed to diversity and inclusion. We do not discriminate based on race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other protected status. Employment decisions are based on qualifications, merit, and business needs.

    Apply Now:

    If you have the experience and skills to excel as a Clinical Research Associate in oncology/hematology, apply today to join BeiGene's innovative team.

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