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    Cra Ii In Neurology - Sponsor Dedicated - Paris Area

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 4, 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

    Clinical Research Associate II - Neurology (Home Based, Paris Area)

    Description
    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities. Our Clinical Development model places the customer and the patient at the center of everything we do, constantly seeking ways to simplify and streamline our processes for a better working relationship.

    Join us in a Functional Service Provider partnership or a Full-Service environment, collaborating with passionate problem solvers to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are committed to changing lives.

    Why Syneos Health?
    We are dedicated to developing our people through career progression, supportive management, technical and therapeutic training, peer recognition, and a comprehensive rewards program. Our Total Self culture allows you to be your authentic self, uniting us globally and emphasizing our commitment to our employees' well-being. By fostering a diverse workplace, we create an environment where everyone feels they belong.

    Job Responsibilities

    • Perform site qualification, initiation, interim monitoring, management, and close-out visits (either on-site or remotely), ensuring compliance with regulatory, ICH-GCP, and/or Good Pharmacoepidemiology Practice (GPP) standards. Evaluate overall site performance and communicate serious issues to the project team, developing action plans as needed.
    • Verify informed consent processes and ensure subject confidentiality. Assess factors affecting subject safety and clinical data integrity, such as protocol deviations and pharmacovigilance issues.
    • As per the Clinical Monitoring/Site Management Plan (CMP/SMP):
      • Assess site processes and conduct source document reviews.
      • Verify the accuracy and completeness of data entered in case report forms (CRFs).
      • Resolve queries and guide site staff, driving query resolution to closure within agreed timelines.
      • Utilize technology to support effective clinical study data review and capture.
      • Ensure compliance with electronic data capture requirements.
    • Conduct investigational product (IP) inventory and reconciliation, verifying proper dispensation according to the protocol.
    • Review the Investigator Site File (ISF) for accuracy and completeness, ensuring timely reconciliation with the Trial Master File (TMF).
    • Document activities through confirmation letters, follow-up letters, trip reports, and communication logs, tracking observations and action items.
    • Understand project scope, budgets, and timelines, managing site-level activities and communication to meet project objectives.
    • Act as a primary liaison with study site personnel and ensure training and compliance of project-specific site team members.
    • Prepare for and attend Investigator Meetings and sponsor meetings, participating in global clinical monitoring/project staff meetings and training sessions.
    • Provide guidance on audit readiness standards and support preparation for audits.

    For Real World Late Phase:

    • Support site activities throughout the study lifecycle from identification to close-out.
    • Perform chart abstraction and data collection.
    • Collaborate with Sponsor affiliates, medical science liaisons, and local country staff.
    • Potentially train junior staff and identify out-of-scope activities.

    Qualifications

    • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
    • Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements.
    • Proficient computer skills and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage required travel of up to 75% regularly.

    Get to Know Syneos Health
    Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites with more than 675,000 trial patients.

    Join us in challenging the status quo in a highly competitive and ever-changing environment. Learn more about Syneos Health.

    Additional Information
    Tasks and responsibilities listed in this job description are not exhaustive. The company may assign other duties at its discretion. Equivalent experience, skills, and education will also be considered, and the company will determine what constitutes equivalent qualifications. This description complies with all obligations imposed by the legislation of each country in which it operates, including the EU Equality Directive. The company is committed to compliance with the Americans with Disabilities Act and will provide reasonable accommodations when appropriate.

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