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    Sponsor Dedicated Cra Ii/ Sr Cra Oncology

    Syneos Health
    2+ years
    Not Disclosed
    Remote - Europe
    10 Sept. 25, 2024
    Job Description
    Job Type: 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

    Position: Sponsor Dedicated CRA II/Sr CRA Oncology - Home-Based (Northern and Central Italy)

    Company Overview: Syneos Health® is a leading integrated biopharmaceutical solutions organization focused on accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to address the evolving needs of the market.

    Our Clinical Development model places customers and patients at the forefront. We strive to simplify our processes, making Syneos Health both easier to collaborate with and work for. Join us in a Functional Service Provider partnership or a Full-Service environment, where you’ll work with passionate problem solvers to help our clients achieve their goals. We are driven to expedite the delivery of therapies because we are dedicated to making a difference in lives.

    Why Work with Us? At Syneos Health, we are committed to your professional growth through career development, supportive management, therapeutic training, and recognition programs. Our Total Self culture fosters an inclusive environment where everyone can be their authentic selves. We believe that diversity of thought, background, and experience enriches our workplace.

    Key Responsibilities:

    • Conduct site qualification, initiation, interim monitoring, management, and close-out visits, ensuring compliance with regulatory standards, ICH-GCP guidelines, and study protocols.
    • Assess the overall performance of sites and staff, communicate serious issues, and develop action plans.
    • Verify informed consent processes and maintain patient confidentiality.
    • Review source documents and medical records to ensure data accuracy in case report forms (CRFs).
    • Resolve queries and provide guidance to site staff, ensuring compliance with electronic data capture requirements.
    • Manage investigational product (IP) inventory, ensuring compliance with protocols and regulatory standards.
    • Maintain the Investigator Site File (ISF) and reconcile it with the Trial Master File (TMF).
    • Document site activities and maintain tracking systems for ongoing observations and action items.
    • Act as the primary liaison with site personnel, ensuring training and compliance with requirements.
    • Participate in investigator meetings and project staff meetings, supporting audit readiness and follow-up actions.
    • For Real World Late Phase studies, act as a Site Management Associate II, supporting site activities and data collection.

    Qualifications:

    • Minimum of 2 years of experience as a Certified CRA per M.D. 15 Nov 2011, with oncology experience required.
    • Strong understanding of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulatory requirements.
    • Proficient in computer skills and adaptable to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Willingness to travel up to 75% regularly.

    Get to Know Syneos Health: Over the past five years, we have collaborated with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, managing over 200 studies across 73,000 sites and 675,000+ trial patients.

    In every role, you will be encouraged to take initiative and challenge the status quo in a dynamic environment. Join us at Syneos Health and be part of a team that values innovation and dedication.

    Additional Information: The responsibilities outlined in this job description are not exhaustive. Syneos Health reserves the right to assign additional tasks as necessary. Equivalent experience, skills, and education will be considered, and the company will determine the equivalence of qualifications. This description does not constitute an employment contract. Syneos Health is committed to compliance with the Americans with Disabilities Act and provides reasonable accommodations as needed.

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