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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

    Job Title: Sponsor Dedicated CRA II/Sr CRA Oncology - Home-Based (Northern or Central Italy)

    Company Overview: Syneos Health® is a premier, fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into actionable outcomes, addressing the complexities of the modern market.

    Our Clinical Development model places both the customer and patient at the center of our efforts. We continuously seek innovative ways to simplify and enhance our processes, making Syneos Health a collaborative and dynamic workplace.

    Why Syneos Health? We are dedicated to developing our people through career advancement opportunities, supportive management, technical and therapeutic training, peer recognition, and comprehensive rewards programs. Our Total Self culture promotes authenticity, ensuring everyone can bring their true selves to work. By fostering diversity in thought, background, and perspective, we create an inclusive environment where everyone belongs.

    Key Responsibilities:

    • Conduct site qualification, initiation, monitoring, management, and close-out visits (both on-site and remotely), ensuring compliance with regulatory standards, ICH-GCP, and protocol requirements. Evaluate site performance, communicate serious issues to the project team, and develop action plans accordingly.
    • Verify informed consent processes for all subjects/patients, ensuring confidentiality and addressing any factors that may impact safety and data integrity at investigation sites.
    • Follow the Clinical Monitoring/Site Management Plan (CMP/SMP) to:
      • Assess site processes and conduct source document reviews.
      • Ensure accuracy and completeness of clinical data entered in case report forms (CRFs).
      • Resolve queries both remotely and on-site, guiding site staff as needed.
      • Utilize necessary technology to support clinical study data review and compliance.
    • Manage investigational product (IP) inventory and storage, ensuring adherence to protocols and regulations.
    • Review the Investigator Site File (ISF) for completeness, ensuring alignment with the Trial Master File (TMF) and compliance with local guidelines for document archiving.
    • Document activities via confirmation letters, trip reports, and communication logs, supporting patient recruitment and retention strategies.
    • Understand project scope, budgets, and timelines, managing site-level activities to meet project objectives and adapting to changing priorities as needed.
    • Serve as the primary liaison with study site personnel, ensuring compliance and training for all assigned sites.
    • Participate in Investigator Meetings, sponsor meetings, and training sessions as required, contributing to audit readiness and supporting necessary follow-up actions.
    • Maintain up-to-date knowledge of ICH/GCP guidelines and complete required training.

    For Real World Late Phase (RWLP) Projects:

    • Support the study lifecycle from site identification to close-out.
    • Engage in chart abstraction activities and data collection.
    • Collaborate with sponsor affiliates and local staff, training junior team members as needed.
    • Identify and communicate out-of-scope activities and suggest potential sites based on local treatment patterns and provider associations.

    Qualifications:

    • Minimum of 2 years of experience as a Certified CRA, with required experience in oncology.
    • Solid understanding of Good Clinical Practice (GCP), ICH guidelines, and relevant regulatory requirements.
    • Proficient computer skills and a willingness to embrace new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage up to 75% travel on a regular basis.

    About Syneos Health: In the past five years, we’ve been involved with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and more than 675,000 trial patients. We encourage you to take initiative and challenge the status quo in our fast-paced environment.

    Additional Information: This job description is not exhaustive; additional tasks may be assigned at the company's discretion. Qualifications may vary among individuals, and the company will determine what constitutes equivalent qualifications. This document does not create an employment contract. Syneos Health is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations when necessary.

    If you’re passionate about making an impact in the oncology field and meet the qualifications, we encourage you to apply.

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