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    Senior Cra / Cra Ii - Sponsor Dedicated - Cardiovascular - Scotland / North East (United Kingdom)

    Syneos Health
    2+ years
    Not Disclosed
    Remote
    10 Oct. 21, 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

    Senior Clinical Research Associate I

    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 patient at the center of everything we do. We continually seek ways to simplify and streamline our processes, making Syneos Health easier to work with and for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

    Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

    Why Syneos Health

    We are passionate about developing our people through career progression, supportive management, technical training, peer recognition, and a comprehensive rewards program. Our Total Self culture allows you to be your authentic self, uniting us globally and ensuring everyone feels they belong.

    Job Responsibilities

    • Perform site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely), ensuring compliance with regulatory guidelines, ICH-GCP, and study protocols.
    • Verify that the informed consent process has been adequately performed and documented for each subject/patient, protecting confidentiality.
    • Assess factors affecting patient safety and data integrity at investigator sites, addressing protocol deviations and pharmacovigilance issues.
    • Conduct Source Document Reviews and verify the accuracy of clinical data entered in case report forms (CRFs).
    • Resolve queries efficiently and provide guidance to site staff, driving query resolution to closure within agreed timelines.
    • Manage investigational product inventory and ensure compliance with protocols and regulations.
    • Review and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF), ensuring proper documentation archiving.
    • Document activities through confirmation letters, trip reports, and other required documents.
    • Support patient recruitment and retention strategies, and track site-level activities to meet project timelines.
    • Act as the primary liaison with study site personnel, ensuring compliance with training requirements.
    • Prepare for and attend Investigator and sponsor meetings, and participate in global clinical monitoring/project staff meetings.
    • Guide audit readiness at the site and project levels, supporting preparation for audits and follow-ups.
    • Provide training or mentorship to junior Clinical Research Associates (CRAs) as needed.

    For Real World Late Phase studies, the Senior CRA I will use the title of Senior Site Management Associate I, with additional responsibilities including:

    • Providing site support throughout the study lifecycle from identification to close-out.
    • Knowledge of local requirements for real-world late phase study designs.
    • Chart abstraction activities and data collection.
    • Collaborating with Sponsor affiliates and local country staff.
    • Identifying potential sites based on local treatment patterns and patient advocacy.

    Qualifications

    What We’re Looking For:

    • 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.
    • Proficiency in 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, conducting over 200 studies across 73,000 sites and 675,000+ trial patients. Join us in taking initiative and challenging the status quo in a competitive and evolving environment.

    Additional Information:

    The tasks, duties, and responsibilities listed in this job description are not exhaustive. The company may assign other tasks at its discretion. Equivalent experience, skills, and education will be considered. This document does not constitute an employment contract.

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