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    Cra Ii - Scra Ii (Perth/ Adelaide)

    Syneos Health
    2+ years
    Not Disclosed
    Remote - Europe
    10 Sept. 25, 2024
    Job Description
    Job Type: Remote 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

    Position: Clinical Research Associate II

    Company Overview:
    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We translate clinical, medical affairs, and commercial insights into actionable outcomes that meet the demands of today’s market.

    Our Clinical Development model centers on both customers and patients, continually seeking ways to streamline processes and enhance collaboration. Whether in a Functional Service Provider partnership or a Full-Service environment, you’ll work alongside dedicated problem solvers, all focused on achieving client goals and advancing therapy delivery.

    Join our team of 29,000 employees across 110 countries and discover why WORK HERE MATTERS EVERYWHERE.

    Why Syneos Health?
    We are committed to the professional growth of our employees through career development opportunities, supportive management, technical training, and a total rewards program. Our "Total Self" culture encourages authenticity and inclusivity, fostering a workplace where diverse perspectives contribute to our success.

    Key Responsibilities:

    • Conduct site qualifications, initiations, monitoring, and close-out visits (both on-site and remotely), ensuring compliance with regulatory standards, ICH-GCP, and protocol requirements.
    • Evaluate site performance and provide actionable recommendations while escalating serious issues to the project team as necessary.
    • Ensure proper informed consent processes are followed and documented, maintaining patient confidentiality and safety.
    • Perform the following tasks according to the Clinical Monitoring/Site Management Plan (CMP/SMP):
      • Assess site processes and conduct Source Document Reviews.
      • Verify the accuracy and completeness of data entered in case report forms (CRFs).
      • Apply query resolution techniques both remotely and on-site, guiding site staff as needed.
      • Ensure compliance with electronic data capture requirements.
    • Manage investigational product (IP) inventory, ensuring it is dispensed according to protocol and addressing any issues related to blinding or randomization.
    • Review the Investigator Site File (ISF) for accuracy and completeness, reconciling it with the Trial Master File (TMF).
    • Document all activities through confirmation letters, trip reports, and other required project documentation, while supporting patient recruitment and retention strategies.
    • Understand project scope, budgets, and timelines, managing site-level communications to ensure project objectives are met.
    • Act as the primary liaison with site personnel, ensuring all team members are trained and compliant with relevant requirements.
    • Prepare for and attend Investigator Meetings and participate in global clinical monitoring/project staff meetings.
    • Maintain audit readiness and assist in preparation for audits and follow-up actions.

    Additional Responsibilities for Real World Late Phase (RWLP):

    • Provide comprehensive site support throughout the study lifecycle, from identification to close-out.
    • Collaborate with internal and external stakeholders, including Sponsor affiliates and medical science liaisons.
    • Identify and report out-of-scope activities to the Lead CRA/Project Manager.
    • Recommend potential sites based on local treatment patterns and patient advocacy insights.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
    • Solid understanding of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulatory requirements.
    • Proficient in computer skills and adaptable to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Willingness to travel up to 75% of the time.

    Get to Know Syneos Health:
    Over the past five years, we have partnered on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, contributing to over 200 studies across 73,000 sites and 675,000+ trial patients.

    No matter your role, you’ll be encouraged to take initiative and challenge the status quo in a competitive, dynamic environment. Learn more about Syneos Health.

    Additional Information:
    This job description is not exhaustive, and responsibilities may evolve as needed. Syneos Health reserves the right to assign additional tasks and responsibilities. Equivalent experience and qualifications will be considered.

    We are committed to compliance with the Americans with Disabilities Act and will provide reasonable accommodations as needed to assist employees and applicants in performing essential job functions.

    If you're interested in this opportunity but unsure about meeting all qualifications, we encourage you to apply—your unique skills may be just what we’re looking for!

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