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    Senior Cra In Oncology

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    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: Senior CRA in Oncology - Home-Based (Paris Area)

    Company Overview: Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We transform clinical, medical, and commercial insights into meaningful outcomes, addressing the complexities of today’s healthcare landscape.

    Our Clinical Development model prioritizes both the customer and the patient. We continuously seek innovative ways to simplify our processes, ensuring that Syneos Health is both a collaborative partner and a fulfilling workplace.

    Why Choose Syneos Health? We are committed to developing our employees through career advancement opportunities, supportive management, technical training, and a comprehensive rewards program. Our Total Self culture encourages authenticity, fostering a diverse and inclusive environment where everyone feels they belong.

    Key Responsibilities:

    • Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote) to ensure compliance with regulatory requirements, ICH-GCP, and study protocols. Utilize judgment and experience to assess site performance and provide actionable recommendations, escalating serious issues as necessary.
    • Ensure that the informed consent process is performed and documented appropriately for each subject, while maintaining confidentiality and assessing factors affecting patient safety and data integrity.
    • Follow the Clinical Monitoring/Site Management Plan (CMP/SMP) to:
      • Evaluate site processes and conduct source document reviews.
      • Verify the accuracy and completeness of clinical data in case report forms (CRFs).
      • Resolve queries effectively and guide site staff in addressing them.
      • Use available technology for clinical study data review and compliance verification.
    • Oversee investigational product (IP) inventory, ensuring proper handling, dispensation, and compliance with relevant regulations.
    • Regularly review the Investigator Site File (ISF) for completeness and accuracy, ensuring it aligns with the Trial Master File (TMF) and complies with local archiving requirements.
    • Document activities through confirmation letters, trip reports, and other required project documentation, supporting subject recruitment and retention strategies.
    • Manage project scope, budgets, and timelines, ensuring site-level activities align with project objectives and adapting to changing priorities.
    • Act as the primary liaison with study site personnel, ensuring compliance and training for all team members.
    • Prepare for and participate in Investigator Meetings, sponsor meetings, and training sessions, contributing to audit readiness and supporting necessary follow-up actions.
    • Maintain current knowledge of ICH/GCP guidelines and complete required training.

    For Real World Late Phase (RWLP) Projects:

    • Provide support throughout the study lifecycle, from site identification to close-out.
    • Conduct chart abstraction and data collection activities.
    • Collaborate with sponsor affiliates and local staff, and may be requested to train junior staff.
    • Identify out-of-scope activities and communicate them to the Lead CRA/Project Manager.
    • Proactively suggest potential sites based on local treatment patterns and healthcare provider associations.

    Qualifications:

    • Bachelor’s degree or RN in a relevant field, or equivalent combination of education, training, and experience.
    • Strong understanding of Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements.
    • Proficient computer skills and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage up to 75% travel regularly.

    About Syneos Health: In the last five years, we have been involved with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites, engaging 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 and may be subject to change at the company's discretion. Equivalent experience or skills will be considered, and qualifications may vary among candidates. This document does not constitute an employment contract. Syneos Health is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations as necessary.

    If you are passionate about making a difference in oncology and meet the qualifications, we encourage you to apply!

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