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    Sr Cra I Barcelona Or Madrid. Sponsor Dedicated

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 5, 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

    Senior Clinical Research Associate I

    Company: Syneos Health®
    Location: [Location specifics not mentioned]
    Job Type: Full-Time

    About Syneos Health:

    Syneos Health® is a global leader in biopharmaceutical solutions, committed to accelerating customer success. We integrate clinical, medical affairs, and commercial insights to address the challenges of the modern healthcare landscape. Our Clinical Development model focuses on putting both the customer and the patient at the center of everything we do. We continuously innovate and simplify our processes to ensure that we are both easier to work with and for.

    With over 29,000 employees across 110 countries, we create a diverse and dynamic environment where collaboration and passion lead to real-world solutions that change lives.

    Why Syneos Health?

    We are passionate about developing our people, offering opportunities for career growth, training, and advancement. Our Total Self culture promotes authenticity, allowing you to bring your true self to work. We are committed to diversity, equity, and inclusion, believing that when we bring together diverse perspectives, everyone feels like they belong.

    We are also focused on offering a range of career development programs, peer recognition, and competitive rewards to support the growth of our employees.

    Job Responsibilities:

    As a Senior Clinical Research Associate I (Sr. CRA I), you will play a critical role in the clinical trial lifecycle, overseeing site management, monitoring, and ensuring regulatory compliance. Your key responsibilities include:

    • Site Monitoring & Management: Perform site qualification, initiation, monitoring (on-site and remotely), and close-out visits. Ensure compliance with regulatory requirements, ICH-GCP guidelines, and protocol.
    • Informed Consent & Patient Safety: Oversee the informed consent process and ensure all safety and data integrity factors are appropriately managed at the site level. Assess risks related to protocol violations, deviations, and pharmacovigilance concerns.
    • Clinical Data Accuracy: Conduct Source Document Reviews and ensure that clinical data entered in the Case Report Form (CRF) is accurate and complete. Resolve queries remotely and on-site, ensuring timely closure.
    • Investigational Product (IP) Management: Ensure proper storage, reconciliation, and handling of investigational products according to protocol, and manage issues related to blinded or randomized information.
    • Document Management: Regularly review and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF). Ensure compliance with regulatory and archival requirements.
    • Project Coordination: Track site performance, budget, timelines, and resource allocation. Communicate regularly with site personnel and ensure the team meets project deliverables.
    • Audit Preparation & Compliance: Ensure site readiness for audits, provide audit support, and help with follow-up actions. Promote audit-ready standards at the site level.
    • Training & Mentorship: Provide guidance and mentorship to junior CRAs and assist with training activities, including conducting training and sign-off visits.
    • Real World Late Phase (RWLP): Support late-phase studies, assist in data collection and chart abstraction, and ensure compliance with country-specific regulations.
    • Collaboration & Communication: Serve as the main point of contact between the site, sponsor, and project team. Build strong relationships and resolve operational issues as they arise.
    • Travel: Up to 75% travel is required for site visits, investigator meetings, and other project activities.

    Qualifications:

    To be successful in this role, you should meet the following requirements:

    • Educational Requirements: A Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
    • Experience: Solid understanding of Good Clinical Practice (GCP) and ICH Guidelines. Previous clinical research experience is preferred (3+ years).
    • Skills & Competencies:
      • Strong computer and data management skills; ability to adopt new technologies.
      • Excellent communication, presentation, and interpersonal skills.
      • Critical thinking and problem-solving abilities.
    • Travel Requirements: Ability to manage up to 75% travel for site visits and meetings.

    Get to Know Syneos Health:

    Syneos Health has supported over 200 studies in 73,000 sites, impacting the approval of 94% of all novel FDA-approved drugs and 95% of EMA-authorized products in the past five years. We pride ourselves on challenging the status quo and driving the future of clinical development.

    Additional Information:

    The responsibilities outlined in this job description are not exhaustive, and the company may assign additional duties as needed. Syneos Health is an equal-opportunity employer, committed to compliance with all applicable regulations, including providing accommodations as required under the Americans with Disabilities Act.

    Ready to make an impact?
    Join Syneos Health and take the next step in your clinical research career. Apply today!

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