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    Senior Cra I - Must Have Neurology (Multiple Sclerosis) Expereince - Sponsor Dedicated - Bulgaria (H

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 13, 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

    About Syneos Health
    Syneos Health® is a global leader in biopharmaceutical solutions, dedicated to accelerating customer success. We deliver integrated clinical, medical affairs, and commercial insights to achieve optimal outcomes that meet the demands of modern healthcare. Our Clinical Development model centers on both the customer and the patient, streamlining work processes to ensure we’re easier to collaborate with and work for.

    Join our diverse team of innovators, problem-solvers, and passionate individuals working together to deliver life-changing therapies. We’re agile, committed, and constantly evolving to provide solutions that make a meaningful impact on patient lives.

    Why Syneos Health
    We invest in career development, offering training, mentorship, and opportunities for progression in a supportive and engaging environment. Our Total Self culture fosters inclusivity and ensures everyone can bring their authentic selves to work. At Syneos Health, diversity of thought, background, and perspective drives innovation and unity across our teams worldwide.

    Responsibilities
    As a Senior Clinical Research Associate I, you will take on a pivotal role in site management and monitoring across all stages of the clinical trial lifecycle. Responsibilities include:

    • Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely), ensuring compliance with ICH-GCP, regulatory standards, and the study protocol.
    • Assess and evaluate site performance, ensuring data integrity, subject safety, and protocol adherence.
    • Review and ensure the process of informed consent is accurately documented and communicated.
    • Perform Source Document Review (SDR), case report form (CRF) verification, and query resolution, driving timely closure of issues.
    • Ensure proper storage, dispensing, and administration of investigational products (IP), complying with GCP and local regulations.
    • Support subject recruitment, retention, and awareness strategies, while tracking ongoing study progress in compliance with project timelines.
    • Manage site-level activities, ensuring deliverables and objectives are met, adapting quickly to changing priorities.
    • Guide junior CRAs through mentorship and training, ensuring they meet operational standards and expectations.
    • Participate in bid defense meetings, and collaborate with cross-functional teams to identify and implement operational efficiencies.

    Additional Responsibilities

    • Provide comprehensive site support throughout the study lifecycle, including site identification and closure.
    • Collaborate with regulatory teams to ensure compliance with local study requirements, and contribute to the development of informed consent forms.
    • Proactively suggest potential sites, based on knowledge of treatment patterns and local healthcare provider networks.
    • Participate in audits and prepare sites for inspections, ensuring audit readiness at all times.

    Qualifications
    We’re looking for professionals with:

    • A Bachelor’s degree or RN in a related field (or equivalent experience).
    • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
    • Strong computer skills and an ability to adapt to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • A critical thinking mindset and a proactive approach to problem-solving.
    • Willingness to travel up to 75% regularly.

    Why Work Here
    Syneos Health works with some of the world’s top pharmaceutical companies, having partnered with 94% of novel FDA-approved drugs and 95% of EMA-authorized products. Join a global leader in clinical trials with over 200 studies conducted across more than 73,000 sites, and 675,000+ trial patients.

    Additional Information
    This job description is not exhaustive. Responsibilities and duties may change based on business needs. Equivalent experience and education may be considered for qualification. Syneos Health is committed to providing reasonable accommodations to employees with disabilities, in compliance with the ADA, to assist in performing essential job functions.

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