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    Sponsor Dedicated Senior Clinical Research Associate - Home Based Norway

    Syneos Health
    2+ years
    Not Disclosed
    Norway
    10 Nov. 23, 2024
    Job Description
    Job Type: Remote Education: RN/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Job Title: Sponsor Dedicated Senior Clinical Research Associate I

    Location: Home-Based, Norway
    Company: Syneos Health

    About Syneos Health

    Syneos Health® is a global, fully integrated biopharmaceutical solutions organization focused on accelerating customer success. By combining clinical, medical, and commercial insights, we deliver impactful results in a rapidly evolving industry.

    With 29,000 employees across 110 countries, we place the customer and patient at the core of our innovative clinical development model. Our teams work collaboratively, embracing agility to expedite the delivery of life-changing therapies.

    Why Work at Syneos Health

    • Career Development: Advance your career through training, recognition programs, and supportive management.
    • Inclusive Culture: Our Total Self culture promotes authenticity, belonging, and well-being for all employees.
    • Global Impact: Contribute to transformative research that changes lives, backed by a collaborative and diverse team.

    Job Responsibilities

    Site Management & Monitoring

    • Conduct site qualification, initiation, interim monitoring, management, and close-out visits (remote or on-site).
    • Ensure compliance with regulatory, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol standards.
    • Assess site processes and staff performance, escalating issues and creating action plans when necessary.
    • Verify informed consent processes and patient confidentiality are maintained.
    • Monitor protocol adherence, identifying risks to patient safety and data integrity.

    Clinical Data Review

    • Conduct source document reviews to ensure data accuracy and completeness.
    • Resolve data queries and provide guidance to site staff.
    • Ensure compliance with electronic data capture (EDC) requirements.

    Investigational Product (IP) Oversight

    • Manage IP inventory, reconciliation, storage, and security.
    • Verify IP dispensing and administration comply with protocol guidelines and regulatory standards.

    Regulatory Documentation & Compliance

    • Review and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF).
    • Maintain accurate documentation, including trip reports, confirmation/follow-up letters, and communication logs.
    • Support patient recruitment and retention initiatives.

    Project & Team Collaboration

    • Act as the primary liaison between project teams and site personnel.
    • Participate in Investigator Meetings, sponsor meetings, and global clinical training sessions.
    • Support audit readiness and assist with preparation and follow-up actions.
    • Provide mentorship to junior CRAs and assist with their training and sign-off visits.

    Real-World Late Phase (RWLP) Studies

    • Support site activities from initiation to close-out.
    • Conduct chart abstraction and data collection.
    • Collaborate with sponsors, medical science liaisons, and local affiliates.
    • Suggest potential sites based on local treatment patterns and patient advocacy.
    • Develop informed consent forms and ensure regulatory compliance.
    • Identify process improvements and operational efficiencies.
    • Participate in bid defense meetings as required.

    Qualifications

    Education & Experience

    • Bachelor’s degree in a related field (e.g., life sciences) or Registered Nurse (RN).
    • Equivalent education, training, and experience may be considered.

    Knowledge & Skills

    • Solid understanding of ICH-GCP Guidelines and applicable regulatory requirements.
    • Proficiency with technology and a willingness to adopt new systems.
    • Strong communication, presentation, and interpersonal skills.
    • Basic critical thinking and problem-solving abilities.
    • Ability to manage travel of up to 75% on a regular basis.

    Get to Know Syneos Health

    • Supported 94% of all Novel FDA-Approved Drugs and 95% of EMA-Authorized Products in the past 5 years.
    • Conducted over 200 studies at 73,000 sites with 675,000+ trial participants.
    • Our mission is to challenge the status quo and innovate in a competitive, ever-changing environment.

    Additional Information

    • Responsibilities may vary based on project requirements.
    • Syneos Health is committed to compliance with the Americans with Disabilities Act (ADA) and provides reasonable accommodations to employees or applicants when necessary.
    • Equivalent qualifications, experience, and skills will be considered.

    Learn more at Syneos Health Website.

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