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    Experienced Cra Georgia (Eu)

    Syneos Health
    2+ years
    Not Disclosed
    Remote - Europe
    10 Oct. 15, 2024
    Job Description
    Job Type: Full Time 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
    Location: Georgia, Europe

    About Syneos Health
    Syneos Health® is a leading integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We transform unique clinical, medical affairs, and commercial insights into outcomes that address today’s market challenges. Our Clinical Development model prioritizes both the customer and patient experience, and we constantly seek to simplify and streamline our processes. By joining us, you will collaborate with a passionate team committed to innovating and delivering therapies that change lives.

    Why Choose Syneos Health?
    At Syneos Health, we are passionate about developing our people. We offer career development opportunities, supportive management, training in technical and therapeutic areas, and a recognition program that rewards excellence. Our Total Self culture encourages authenticity and inclusivity, fostering an environment where everyone can thrive. Together, we are building a workplace where diversity of thought, background, and culture leads to a sense of belonging.

    Key Responsibilities

    • Conduct site qualification, initiation, interim monitoring, management, and close-out visits, ensuring compliance with regulatory guidelines, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols.
    • Evaluate site performance and staff, recommending actions as necessary, while promptly communicating serious issues to the project team and developing action plans.
    • Verify informed consent processes, safeguarding patient confidentiality, and assess factors affecting patient safety and clinical data integrity.
    • Assess site processes per the Clinical Monitoring/Site Management Plan, conducting Source Document Reviews and ensuring data accuracy in case report forms (CRFs).
    • Resolve queries with site staff, ensuring timely closure, and verify compliance with electronic data capture requirements.
    • Oversee investigational product inventory and ensure proper documentation and compliance with local regulations.
    • Maintain the Investigator Site File (ISF) accuracy and ensure essential documents are archived appropriately.
    • Document activities through letters, reports, logs, and other required project documentation.
    • Support patient recruitment and retention strategies while entering data into tracking systems.
    • Manage site-level communications and activities to ensure project objectives are met, adapting quickly to changing priorities.
    • Act as a liaison with project site personnel and participate in Investigator Meetings and project staff meetings.
    • Prepare for audits, guiding site and project-level audit readiness, and may mentor junior CRAs.

    Qualifications

    • Bachelor’s degree or RN in a relevant field or equivalent education and experience.
    • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements.
    • Proficient in computer skills and adaptable to new technologies.
    • Strong communication, presentation, and interpersonal skills, with basic critical thinking abilities.
    • Willingness to travel up to 75% regularly.

    Get to Know Us
    In the past five years, we have collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, managing over 200 studies across 73,000 sites and more than 675,000 trial patients.

    At Syneos Health, you will have the opportunity to challenge the status quo and thrive in a dynamic, competitive environment.

    Additional Information
    This job description is not exhaustive. The company may assign other responsibilities as needed. Qualifications may vary based on experience, skills, and education. We are committed to complying with the Americans with Disabilities Act and providing reasonable accommodations when appropriate.

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