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    Sr Cra I - Sponsor Dedicated - Hungary

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 6, 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: Senior Clinical Research Associate I (Single Sponsor - FSP)
    Company: Syneos Health®

    About Syneos Health:
    Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our mission is to improve patient outcomes by translating unique clinical, medical affairs, and commercial insights into actionable solutions. Whether through Functional Service Provider (FSP) partnerships or Full-Service environments, we focus on simplifying clinical trials, streamlining operations, and ensuring faster delivery of life-changing therapies. Our employees are passionate about driving change, solving complex problems, and innovating within the biopharmaceutical industry.

    Why Syneos Health:
    At Syneos Health, we are deeply committed to the development of our people, offering continuous career development, engaging line management, technical training, and a comprehensive total rewards program. Our "Total Self" culture empowers our people to be their authentic selves, uniting us globally and fostering a supportive work environment. Join us and be part of a company that thrives on diversity, creativity, and a shared mission to improve lives.

    Job Description:

    The Senior Clinical Research Associate I will manage and monitor clinical trials for single sponsor clients within the Functional Service Provider (FSP) model. You will be responsible for performing all site management activities, ensuring protocol compliance, and maintaining high standards of clinical operations. Your work will span from site qualification through to close-out visits, ensuring data integrity, patient safety, and adherence to regulatory requirements.

    Key Responsibilities:

    • Site Management: Perform site qualification, initiation, monitoring, and close-out visits, ensuring compliance with ICH-GCP, protocol, and regulatory standards.
    • Data Integrity: Ensure clinical data accuracy by reviewing source documents, case report forms (CRFs), and medical records. Drive query resolution and ensure timely closure.
    • Safety and Compliance: Monitor and document safety issues, protocol deviations, and pharmacovigilance concerns, while maintaining patient confidentiality.
    • Regulatory Oversight: Confirm informed consent is properly obtained, assess investigational product (IP) handling and storage, and ensure compliance with regulatory guidelines and SOPs.
    • Site Files and Documentation: Review and maintain accurate Investigator Site Files (ISF) and ensure they are reconciled with the Trial Master File (TMF). Provide proper documentation of all site activities and communications.
    • Training and Support: Provide training and mentorship to junior CRAs, and assist with investigator meetings and sponsor face-to-face meetings. Support audit readiness activities.
    • Project Coordination: Assist in managing site-level project activities, including recruitment and retention strategies, to ensure that project deliverables, timelines, and budgets are met.
    • Site Relationship Management: Build and maintain relationships with site personnel, communicate site-specific issues to project teams, and proactively suggest potential sites based on local treatment patterns and healthcare provider knowledge.
    • Late Phase Real World (RWLP) Studies: Support real world late-phase studies by performing chart abstraction activities and providing support throughout the study lifecycle.

    Additional Responsibilities:

    • Proactively identify and resolve operational challenges, suggest process improvements, and drive site performance.
    • Collaborate with sponsor teams, regulatory affairs, and medical liaisons for country-level regulatory compliance and study design input.
    • Provide input for bid defense meetings and contribute to the selection of potential sites for future studies.

    Qualifications:

    What we’re looking for:

    • Education: Bachelor’s degree or Registered Nurse (RN) in a related field, or equivalent combination of education, training, and experience.
    • Experience: Previous experience as a CRA, with a solid understanding of ICH/GCP guidelines, clinical trial protocols, and regulatory requirements.
    • Skills: Proficient computer skills and familiarity with clinical trial management software. Ability to embrace new technologies.
    • Travel Requirements: Ability to manage up to 75% travel on a regular basis.
    • Communication: Strong communication, presentation, and interpersonal skills, with a basic level of critical thinking.

    About Syneos Health’s Impact:
    Syneos Health has contributed to the success of 94% of all Novel FDA-approved drugs and 95% of EMA Authorized products. With over 200 studies across more than 73,000 sites, we’ve touched the lives of over 675,000 trial participants. By joining Syneos Health, you become part of an organization with a significant global footprint and a relentless passion to bring therapies to market faster.

    Why Work at Syneos Health?

    At Syneos Health, you’ll join a dynamic team of professionals dedicated to improving lives globally. We offer ongoing professional development opportunities, a collaborative work environment, and a commitment to work-life balance. Whether you're starting or advancing your career, Syneos Health offers the resources, support, and opportunities you need to succeed.

    Syneos Health is an Equal Opportunity Employer
    We embrace diversity in all its forms and are committed to providing an inclusive and accessible workplace for all candidates. We welcome applications from all qualified individuals without regard to race, religion, gender, age, disability, or any other protected status.

    If you're excited about contributing to the success of groundbreaking clinical trials and helping change the lives of patients, apply today!

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