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    Sponsor Dedicated Senior Clinical Research Associate - Home Based Norway

    Syneos Health
    None years
    Not Disclosed
    Norway
    10 Nov. 23, 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

    Job Description: Sponsor Dedicated Senior Clinical Research Associate I - Home Based (Norway)

    Company: Syneos Health®
    Location: Home-based, Norway

    Company Overview:

    Syneos Health® is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. The company integrates clinical, medical affairs, and commercial insights to drive outcomes that meet the demands of modern markets. With a focus on customer and patient-centered approaches, Syneos Health innovates to streamline clinical development, making their services easier to work with while fostering a dynamic and diverse culture.

    With 29,000 employees across 110 countries, Syneos Health is a globally recognized organization that fosters a culture where everyone belongs and thrives. They are committed to professional growth, a supportive work environment, and a "Total Self" culture.

    Role Overview:

    As a Sponsor Dedicated Senior Clinical Research Associate I, you will be responsible for overseeing the successful management of clinical sites from site initiation to close-out, ensuring adherence to regulatory standards and protocol compliance. The role also involves significant site management responsibilities, including site performance evaluation, informed consent verification, clinical data integrity, and communication with various stakeholders to ensure smooth trial progress.

    Key Responsibilities:

    • Site Management & Monitoring:

      • Perform site qualification, initiation, monitoring, and close-out visits, ensuring regulatory, ICH-GCP, and protocol compliance.
      • Evaluate site performance and provide recommendations for corrective actions when necessary.
      • Escalate serious issues to the project team and develop action plans.
      • Ensure the confidentiality of patient data and safety during clinical trials.

    • Data Integrity & Query Resolution:

      • Review site source documents and medical records to verify the accuracy and completeness of data entered into case report forms (CRFs).
      • Resolve data queries both remotely and on-site, providing guidance to site staff and ensuring resolution within specified timelines.

    • Investigational Product (IP) Management:

      • Oversee IP inventory and reconciliation, ensuring proper storage and security.
      • Verify that investigational products are dispensed and administered according to the study protocol, and manage risks associated with blinded or randomized information.

    • Documentation & Compliance:

      • Maintain up-to-date Investigator Site Files (ISF) and reconcile them with the Trial Master File (TMF).
      • Ensure that essential documents are archived according to local regulatory guidelines.
      • Document activities and communicate status through confirmation letters, trip reports, and follow-up communications.

    • Project & Site-Level Management:

      • Manage site-level activities to meet project goals, timelines, and deliverables.
      • Collaborate with site personnel and the project team to ensure compliance and communication across all phases of the trial.

    • Training & Mentorship:

      • Provide training and mentorship to junior CRAs and assist with training visits as needed.
      • Participate in investigator meetings and global project staff meetings.
      • Help prepare sites for audits and ensure audit readiness.

    • Real World Late Phase (RWLP) Studies:

      • Support the site lifecycle in RWLP studies, from site identification through to close-out.
      • Participate in chart abstraction, data collection, and the development of country-level informed consent forms.
      • Proactively suggest potential sites based on local treatment patterns and healthcare provider relationships.
      • Collaborate with the RWLP regulatory team to ensure updated regulatory information is applied.

    Qualifications:

    • Education:

      • Bachelor’s degree or Registered Nurse (RN) in a related field, or equivalent combination of education, training, and experience.

    • Experience & Skills:

      • Knowledge of Good Clinical Practice (GCP), ICH guidelines, and regulatory requirements.
      • Proficiency in computer skills and the ability to adapt to new technologies.
      • Excellent communication, presentation, and interpersonal skills.
      • Ability to think critically and manage complex tasks and responsibilities.

    • Additional Skills:

      • Ability to manage up to 75% travel on a regular basis.
      • Strong ability to work independently while maintaining effective communication and collaboration with global teams.

    Why Syneos Health?

    Syneos Health offers a dynamic and supportive environment for career development, progression, and learning. With a commitment to fostering a diverse and inclusive culture, Syneos Health ensures that employees can bring their authentic selves to work and contribute meaningfully to the company’s growth. Benefits include technical and therapeutic training, career development programs, and a comprehensive Total Rewards program.

    Join Syneos Health and be part of a global team that is driving innovation in clinical research.

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