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    Cra Freelance Italia - 0.5 Fte

    Syneos Health
    0-2 years
    Not Disclosed
    Remote, USA
    10 Nov. 6, 2024
    Job Description
    Job Type: Full Time 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 II
    Company: Syneos Health®
    Location: [Insert Location or specify remote work]

    About Syneos Health:

    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by transforming clinical, medical, and commercial insights into actionable outcomes. With a focus on simplifying and streamlining operations, we help to drive progress in clinical development while ensuring we’re easier to collaborate with—and work for.

    Join our team of passionate problem solvers in an agile environment dedicated to improving patient outcomes and accelerating the delivery of life-changing therapies.

    Why Syneos Health?

    At Syneos Health, we are committed to developing our people, fostering career progression, providing engaging training, and recognizing achievements through our Total Rewards program. We nurture a Total Self culture, where everyone is encouraged to bring their authentic self to work. This culture of diversity and inclusion unites us globally, creating an environment where everyone feels valued.

    Job Responsibilities:

    Site Management & Monitoring:

    • Perform site qualification, initiation, interim monitoring, and close-out visits, either on-site or remotely, ensuring compliance with ICH-GCP, Good Pharmacoepidemiology Practices (GPP), and study protocols.
    • Evaluate site and staff performance, escalate significant issues, and develop corrective action plans.
    • Verify the informed consent process and ensure the protection of patient confidentiality and safety throughout the study.
    • Conduct Source Document Review (SDR) and Source Data Verification (SDV) to ensure accurate and complete clinical data entry in Case Report Forms (CRFs).
    • Resolve data queries in collaboration with site staff and ensure timely query resolution.
    • Review and ensure compliance with electronic data capture systems and study requirements.

    Investigational Product (IP) Management:

    • Oversee IP inventory and ensure the secure storage, dispensing, and proper administration of the investigational product according to study protocols and local regulations.
    • Ensure compliance with blinded and randomized IP information.

    Site Communication & Documentation:

    • Maintain accurate and up-to-date records in the Investigator Site File (ISF), Trial Master File (TMF), and all related project documents.
    • Enter site monitoring activities, findings, and action items into tracking systems.
    • Support subject recruitment and retention strategies, assisting site staff in ensuring successful recruitment and patient awareness.

    Training & Mentorship:

    • Train and mentor junior CRAs, ensuring they are prepared for monitoring visits and project tasks.
    • Support audit readiness, prepare sites for audits, and manage any follow-up actions.

    Project & Sponsor Interaction:

    • Participate in Investigator Meetings and sponsor face-to-face meetings.
    • Lead or participate in global clinical monitoring/project meetings and provide updates on study progress.
    • Contribute to business development activities and assist with site management strategy development for proposals.

    Real World Late Phase (RWLP) Studies (if applicable):

    • Provide support throughout the study lifecycle, from site identification to study close-out.
    • Conduct chart abstraction activities and data collection.
    • Engage with Sponsor teams, Medical Science Liaisons, and local country staff to ensure study objectives are met.
    • Identify operational efficiencies and propose process improvements for RWLP studies.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
    • Solid understanding of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulatory requirements.
    • Strong computer skills and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to travel up to 75% for site visits and study activities.

    Why Work at Syneos Health?

    • Syneos Health has worked on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and supported over 200 studies across 73,000 sites.
    • We offer a comprehensive benefits package, including health insurance, retirement plans, wellness programs, and more.

    Ready to make an impact? Explore the opportunities and apply today at Syneos Health, where work matters everywhere.

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