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    Cra Ii - Must Have Immuno-Inflammation Expereince - Sponsor Dedicated - Bulgaria (Homebased)

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 21, 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

    Job Title: Clinical Research Associate II
    Company: Syneos Health
    Location: Remote/Various Locations (Travel Required)

    About Syneos Health:
    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates client success. By translating clinical, medical affairs, and commercial insights into real-world outcomes, we address the evolving market challenges that impact the delivery of therapies. We prioritize simplicity and efficiency, always striving to make Syneos Health easier to work with and for. Our approach places the patient and customer at the heart of everything we do.

    Why Syneos Health:

    We are passionate about developing our people through career growth, training, mentorship, and a Total Self culture that fosters an inclusive and supportive environment. By embracing diverse perspectives and experiences, we aim to create a place where every employee feels like they belong. Join us, and contribute to the future of clinical research.

    Job Overview:

    The Clinical Research Associate II (CRA II) will be responsible for conducting site qualification, initiation, monitoring, and close-out visits, ensuring adherence to regulatory, ICH-GCP, and protocol compliance. You will manage site performance, ensuring data integrity, patient safety, and successful study outcomes. You will work closely with site teams to ensure project timelines, budgets, and objectives are met.

    Key Responsibilities:

    • Perform site qualification, initiation, interim monitoring, and close-out visits (either on-site or remotely), ensuring full compliance with regulatory guidelines (ICH-GCP, GPP) and study protocols.
    • Assess site performance, identify issues, and collaborate with site staff to develop corrective action plans for any serious issues, ensuring protocol compliance.
    • Verify the informed consent process and ensure all required documentation is completed and accurate.
    • Perform Source Document Reviews to verify accuracy and completeness of data entered in Case Report Forms (CRFs).
    • Apply query resolution techniques to drive issue resolution within agreed timelines, ensuring data quality.
    • Manage Investigational Product (IP) inventory, reconciliation, and storage, ensuring it is dispensed and administered per protocol.
    • Review Investigator Site Files (ISF) for accuracy, completeness, and timely filing. Reconcile with Trial Master File (TMF) and ensure compliance with archiving requirements.
    • Document activities through trip reports, confirmation letters, and other project documents as required by SOPs and the Clinical Monitoring Plan.
    • Support subject recruitment and retention strategies; manage site-level communication to ensure project objectives are met.
    • Prepare for and attend Investigator Meetings and other sponsor-facing events; participate in global clinical monitoring meetings.
    • Provide guidance for audit readiness and assist in audit preparation and follow-up actions.
    • In Real World Late Phase (RWLP), provide site support through the entire study lifecycle, including site identification, chart abstraction, and data collection.
    • Collaborate with sponsor affiliates, medical science liaisons, and local country teams to ensure study success.
    • Provide mentorship and training to junior staff, as needed.
    • Contribute to process efficiencies and suggest improvements based on field experience.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
    • Proficient in Good Clinical Practice (GCP), ICH Guidelines, and other regulatory requirements.
    • Demonstrated proficiency with clinical monitoring, data collection, and electronic data capture tools.
    • Strong communication, organizational, and interpersonal skills.
    • Ability to manage up to 75% travel regularly.
    • Basic critical thinking skills to analyze site performance and ensure quality.

    Get to know Syneos Health:

    Syneos Health has been a key player in advancing 94% of all novel FDA-approved drugs and 95% of EMA-authorized products, managing over 200 studies across 73,000 sites and 675,000+ trial patients globally.

    Apply Now: Syneos Health Careers

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