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    Cra Ii

    Syneos Health
    2 year years
    Not Disclosed
    Remote - Europe
    10 Nov. 20, 2024
    Job Description
    Job Type: Full Time Education: BSc/MSC/Bpharm/Mpharm/lifesciences 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

    The Clinical Research Associate (CRA) - Sponsor Dedicated position at Syneos Health focuses on overseeing and managing clinical trials in the areas of Immunology, Oncology, and Hematology. The CRA will play a key role in ensuring site compliance with regulatory and protocol requirements, conducting site visits (both on-site and remotely), and supporting the overall success of clinical trials by managing relationships with investigators, ensuring data integrity, and handling investigational products.

    Key Responsibilities:

    • Site Monitoring & Management: The CRA will perform site qualification, initiation, interim monitoring, and close-out visits, ensuring compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and company SOPs. The CRA will assess site processes and performance and communicate/escalate any serious issues to the project team.
    • Data Review & Query Resolution: Conduct source document reviews, verify clinical data accuracy in case report forms (CRFs), and resolve data queries with site staff. The CRA ensures accurate entry of data into the system, addressing issues that arise with timely resolution.
    • Regulatory Compliance & Documentation: Ensures informed consent is obtained and documented correctly. Verifies the safety of patients, ensures confidentiality, and addresses any pharmacovigilance issues. Regularly reviews the Investigator Site File (ISF) and ensures essential documents are filed according to regulations.
    • Investigational Product (IP) Management: The CRA ensures investigational product inventory and storage are handled per the protocol and regulatory requirements.
    • Site Communication & Support: Act as the liaison between the sponsor and the site, ensuring smooth communication and that all site staff are trained and compliant with applicable guidelines.
    • Audit Readiness & Training: Support audit preparation and provide ongoing clinical trial training as needed.

    Qualifications:

    • Education: A bachelor’s degree in a related field or an RN (Registered Nurse) qualification. Equivalent experience may also be considered.
    • Experience: Experience in clinical research and knowledge of ICH/GCP guidelines is crucial. A solid understanding of clinical trial processes and regulations is required.
    • Skills: Excellent communication, interpersonal, and organizational skills. Strong computer literacy and the ability to quickly adapt to new technologies.
    • Travel: Willingness to travel up to 75% as required.

    Why Syneos Health?

    Syneos Health offers a culture focused on career development, inclusion, and diversity, alongside a commitment to employee well-being. The company prides itself on its global impact, having worked with major pharmaceutical companies on numerous clinical trials for newly approved drugs. Employees are empowered to challenge the status quo and collaborate as problem solvers in a dynamic environment.

    If you're interested in working for a company that values both individual and team contributions and is dedicated to improving lives through innovative clinical solutions, Syneos Health might be a great fit for you.

     

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