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    Senior Cra France - Contractor

    Syneos Health
    5+ years
    Not Disclosed
    Remote - Europe
    10 Aug. 16, 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

    Position: Senior Clinical Research Associate (Contractor) - France

    Company: Syneos Health®

    About Us:

    Syneos Health® is a leading global biopharmaceutical solutions organization dedicated to accelerating customer success. We offer integrated clinical, medical affairs, and commercial solutions to address modern market challenges. Our approach centers on simplifying and streamlining our processes to benefit both our clients and our employees. With a team of over 29,000 professionals across 110 countries, we are passionate about making a difference and delivering therapies that change lives.

    Why Syneos Health:

    • Career Growth: We are committed to developing our people through career progression, supportive management, specialized training, and recognition programs.
    • Inclusive Culture: Our Total Self culture fosters authenticity and inclusivity, creating a workplace where everyone feels they belong.
    • Innovative Environment: Join a team of problem solvers dedicated to transforming clinical research and accelerating therapy delivery.

    Role Overview:

    We are seeking an experienced Senior Clinical Research Associate (CRA) to join our team in France. This contractor role involves performing site qualification, initiation, monitoring, management, and close-out visits, both on-site and remotely. The CRA will ensure compliance with regulatory standards, ICH-GCP guidelines, and study protocols, while managing site performance and addressing any issues.

    Key Responsibilities:

    • Site Management:

      • Conduct site qualification, initiation, interim monitoring, and close-out visits.
      • Ensure compliance with regulatory requirements, ICH-GCP guidelines, and study protocols.
      • Evaluate site performance, communicate serious issues to the project team, and develop action plans.
      • Verify informed consent processes and protect subject confidentiality.

    • Data and Documentation:

      • Review source documents and medical records, and verify the accuracy and completeness of clinical data in CRFs.
      • Manage query resolution, investigational product (IP) inventory, and ensure proper IP handling.
      • Maintain and reconcile Investigator Site File (ISF) and Trial Master File (TMF).
      • Document activities and manage data tracking systems.

    • Collaboration:

      • Act as a liaison with site personnel and central monitoring associates.
      • Prepare for and attend Investigator Meetings, sponsor meetings, and global clinical monitoring/project staff meetings.
      • Provide guidance on audit readiness and support audit preparations.

    • Mentorship:

      • Provide supervision, training, and mentorship to junior CRAs.
      • Participate in business development proposals and meetings as needed.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or equivalent education and experience.
    • Extensive knowledge of Good Clinical Practice (GCP) and regulatory requirements.
    • Previous monitoring experience in France.
    • Fluency in French and proficiency in English.
    • Strong computer skills and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage travel up to 75% of the time.

    Get to Know Syneos Health:

    In the past 5 years, we have been involved in 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, managing over 200 studies across 73,000 sites with more than 675,000 trial patients. Join us to be part of a dynamic team that thrives on innovation and making an impact.

    Additional Information:

    Tasks and responsibilities listed are not exhaustive. Syneos Health may assign additional duties as needed. We are committed to providing reasonable accommodations to support our employees and applicants in performing essential job functions.

    Apply Now:

    Not ready to apply? Join our Talent Network to receive updates on future opportunities and company news.

    Syneos Health is an equal opportunity employer. We encourage applicants of all backgrounds to apply and look forward to considering your application.

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