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

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Oct. 22, 2024
    Job Description
    Job Type: Full Time Remote 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

    Company Overview:

    Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We transform clinical, medical affairs, and commercial insights into effective outcomes, addressing modern market realities.

    Our Clinical Development model places the customer and patient at the heart of our operations. We continually seek to simplify and streamline processes, making Syneos Health easier to partner with and a great place to work.

    Join our 29,000 employees across 110 countries and discover why:

    WORK HERE MATTERS EVERYWHERE.

    Why Syneos Health:

    • Commitment to career development and progression through supportive management and training.
    • Emphasis on our Total Self culture, fostering an environment where you can authentically be yourself.
    • Focus on building a diverse, inclusive workplace where everyone feels they belong.

    Job Responsibilities:

    • Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote), ensuring compliance with regulatory, ICH-GCP, and protocol standards.
    • Evaluate site performance and staff, communicating serious issues and developing action plans as necessary.
    • Verify informed consent processes and protect patient confidentiality.
    • Assess safety factors affecting clinical data integrity, such as protocol deviations and pharmacovigilance issues.
    • Conduct Source Document Reviews, ensuring accuracy and completeness of clinical data entered in case report forms (CRFs).
    • Apply query resolution techniques and guide site staff to close queries within set timelines.
    • Ensure compliance with electronic data capture requirements and manage investigational product (IP) inventory and security.
    • Review the Investigator Site File (ISF) for accuracy and reconcile it with the Trial Master File (TMF).
    • Document activities through confirmation letters, trip reports, and other required project documents.
    • Manage site-level activities, ensuring project objectives and timelines are met.
    • Act as a primary liaison with project site personnel and ensure compliance with training requirements.
    • Prepare for and attend Investigator Meetings and participate in project staff meetings.
    • Support audit readiness standards and provide training or mentorship to junior CRAs.

    Additional Responsibilities:

    • Provide site support throughout the study lifecycle.
    • Collaborate with local teams and identify potential sites based on treatment patterns and healthcare provider associations.
    • Propose operational efficiencies and process improvements.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
    • Knowledge of Good Clinical Practice/ICH Guidelines and relevant regulatory requirements.
    • Strong computer skills and ability to embrace new technologies.
    • Excellent communication, presentation, and interpersonal skills; basic critical thinking skills expected.
    • Ability to manage travel of up to 75% regularly.

    Get to Know Syneos Health: In the past 5 years, we've collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000+ trial patients.

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

    Additional Information: The responsibilities listed are not exhaustive, and the company may assign additional tasks as necessary. Equivalent experience and skills may also be considered. This description does not create an employment contract, and Syneos Health is committed to compliance with the Americans with Disabilities Act, including providing reasonable accommodations when appropriate.

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