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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 focused on accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into impactful outcomes that address modern market challenges. Our Clinical Development model centers on the customer and the patient, constantly seeking ways to streamline processes to enhance collaboration.

    Joining us means working alongside passionate problem solvers in either a Functional Service Provider partnership or a Full-Service environment, where we innovate as a team to help our customers achieve their goals. We are driven to accelerate the delivery of therapies because we are dedicated to changing lives.

    Why Syneos Health?
    We are committed to developing our people through career growth opportunities, supportive management, technical training, and a comprehensive rewards program. Our Total Self culture encourages authenticity and unity globally, ensuring that everyone feels they belong.

    Job Responsibilities

    • Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (either on-site or remotely) to ensure compliance with regulatory standards, ICH-GCP, and Good Pharmacoepidemiology Practice (GPP). Evaluate site performance and communicate critical issues to the project team, formulating action plans as needed.
    • Ensure informed consent processes are properly executed and documented, safeguarding subject confidentiality while assessing factors affecting subject safety and clinical data integrity.
    • Following 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).
      • Resolve queries using remote and on-site techniques, providing guidance to site staff as necessary.
      • Utilize technology to support effective clinical study data review and compliance with electronic data capture requirements.
    • Manage investigational product (IP) inventory, ensuring proper dispensing and administration according to protocols while addressing any risks related to blinded or randomized information.
    • Regularly review the Investigator Site File (ISF) for accuracy and timeliness, ensuring it aligns with the Trial Master File (TMF) and meets archiving requirements.
    • Document activities through confirmation letters, follow-up correspondence, trip reports, and communication logs per SOPs and the Clinical Monitoring Plan/Site Management Plan. Assist in subject recruitment and retention strategies.
    • Understand project scope, budgets, and timelines; manage site-level communication to ensure project objectives and timelines are met, adapting to changing priorities as needed.
    • Serve 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 necessary 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 relevant regulatory requirements.
    • Strong computer skills and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Willingness to manage travel of up to 75% regularly.

    Get to Know Syneos Health
    In the past five years, we have worked 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 taking initiative and challenging the status quo within a competitive and dynamic environment. Learn more about Syneos Health.

    Additional Information
    The responsibilities outlined in this job description are not exhaustive. The company may assign additional tasks 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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