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    Clinical Research Associate Ii - Sponsor Dedicated

    Syneos Health
    1+ years
    Not Disclosed
    Remote, USA
    10 July 26, 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, 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: Clinical Research Associate II

    Company: Syneos Health®

    Location: Remote / Flexible

    About Syneos Health:
    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to address modern market challenges. Our Clinical Development model centers around the customer and the patient, striving to simplify and streamline processes to enhance both client and employee experiences. Join our 29,000 employees across 110 countries and discover why working here matters everywhere.

    Why Syneos Health?

    • Career Growth: We are committed to the professional development of our people through career progression opportunities, supportive management, technical training, and recognition programs.
    • Inclusive Culture: Our Total Self culture fosters an environment where you can be your authentic self. We believe that diversity of thought, background, and perspective creates a workplace where everyone feels they belong.
    • Continuous Improvement: We are dedicated to building a company where employees thrive and customers succeed by bringing together diverse viewpoints to drive innovation.

    Job Responsibilities:

    • Site Management: Conduct site qualification, initiation, interim monitoring, management, and close-out visits (both on-site and remotely). Ensure compliance with regulatory standards, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) guidelines. Evaluate site performance, address serious issues, and develop action plans.
    • Informed Consent: Verify that informed consent processes are performed and documented properly, ensuring confidentiality and assessing factors affecting subject safety and data integrity.
    • Clinical Monitoring:
      • Assess site processes and conduct Source Document Reviews.
      • Verify accuracy and completeness of clinical data in case report forms (CRFs).
      • Resolve queries and provide guidance to site staff.
      • Ensure compliance with electronic data capture requirements.
    • Investigational Product (IP) Management: Oversee IP inventory, reconciliation, and verify protocol compliance for dispensing and administration. Ensure appropriate labeling, importation, and handling of IP.
    • Documentation: Maintain and reconcile Investigator Site File (ISF) and Trial Master File (TMF). Ensure proper archiving of essential documents.
    • Reporting: Document activities in confirmation letters, trip reports, and communication logs. Support recruitment, retention, and awareness strategies.
    • Project Management: Understand project scope, budgets, and timelines; manage site-level activities to meet project objectives. Adapt to changing priorities.
    • Site Liaison: Act as primary liaison with study site personnel and ensure compliance with requirements. Prepare for and attend Investigator and sponsor meetings.
    • Audit Readiness: Provide guidance for audit preparation and follow-up actions. Maintain knowledge of ICH/GCP guidelines and complete required training.
    • Real World Late Phase (if applicable): Support site activities throughout the study lifecycle, knowledge of local requirements, and training of junior staff. Suggest potential sites based on local knowledge and collaborate with various stakeholders.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or equivalent education, training, and experience.
    • Knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
    • Strong computer skills and ability to embrace new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage up to 75% travel.

    Additional Information:

    Syneos Health offers a comprehensive benefits package including health benefits (Medical, Dental, Vision), a 401k plan with company match, an Employee Stock Purchase Plan, commissions/bonuses, and flexible paid time off. Salary ranges from $63,090 to $145,000 annually, depending on qualifications and experience. Syneos Health complies with federal, state, and municipal regulations regarding paid sick time and vaccination policies.

    Application Details:

    If your experience doesn’t align perfectly with the job description, we still encourage you to apply. We value transferable skills and diverse backgrounds. Join our Talent Network to stay connected with additional career opportunities.

    #LI-SC #LI-Remote

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