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    Cra Ii Barcelona Or Madrid. Sponsor Dedicated

    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

    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 both the customer and the patient at the center of everything we do, continuously seeking ways to simplify and streamline our processes to enhance collaboration.

    Join us in a Functional Service Provider partnership or a Full-Service environment, where you’ll collaborate 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 passionate about developing our people through career development and progression, supportive management, technical training, peer recognition, and a comprehensive rewards program. Our Total Self culture fosters authenticity and unity globally, emphasizing our commitment to our employees' well-being. By bringing together diverse thoughts, backgrounds, cultures, and perspectives, we create an environment where everyone feels they belong.

    Job Responsibilities

    • Perform site qualification, initiation, interim monitoring, management activities, and close-out visits (on-site or remotely), ensuring compliance with regulatory standards, ICH-GCP, and Good Pharmacoepidemiology Practice (GPP). Evaluate overall site performance and communicate serious issues to the project team, developing action plans as necessary.
    • Verify informed consent processes and protect subject confidentiality while assessing factors affecting subject safety and clinical data integrity at investigator sites.
    • In line with the Clinical Monitoring/Site Management Plan (CMP/SMP):
      • Assess site processes and conduct source document reviews.
      • Verify the accuracy and completeness of clinical data in case report forms (CRFs).
      • Apply query resolution techniques and provide guidance to site staff, driving resolution to closure within agreed timelines.
      • Utilize technology to support effective clinical study data review and compliance with electronic data capture requirements.
    • Manage investigational product (IP) inventory, ensuring compliance with protocols and local regulations regarding labeling and storage.
    • Review the Investigator Site File (ISF) for accuracy, ensuring timely reconciliation with the Trial Master File (TMF).
    • Document activities through required project documentation and support subject recruitment and retention strategies.
    • Understand project scope, budgets, and timelines, managing site-level communication to ensure objectives and deliverables are met.
    • Act as a primary liaison with study site personnel and ensure compliance among project-specific site team members.
    • Prepare for and attend Investigator Meetings and participate in global clinical monitoring meetings as required.
    • Maintain a working knowledge of ICH/GCP Guidelines and complete required training.

    For Real World Late Phase:

    • Provide site support throughout the study lifecycle, from identification to close-out.
    • Conduct chart abstraction activities and collaborate with Sponsor affiliates and local staff.
    • Potentially train junior staff and communicate out-of-scope activities to the Lead CRA/Project Manager.

    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.
    • Strong computer skills and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage travel of up to 75% regularly.

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

    Join us in challenging the status quo within a competitive and dynamic environment. Learn more about Syneos Health.

    Additional Information
    The tasks and responsibilities outlined in this job description are not exhaustive. The company may assign additional duties at its discretion. Equivalent experience, skills, and education will also be considered. This description complies with all obligations imposed by legislation in each operating country, including the EU Equality Directive. The company is committed to the Americans with Disabilities Act and will provide reasonable accommodations when appropriate.

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