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    Freelance Srcra Role, 1 Fte For 5 Month Period. Uk & Ireland Sites

    Syneos Health
    2+ years
    Not Disclosed
    Remote
    10 Oct. 22, 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 / SrCRA

    About Us: 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 continuously seek ways to simplify and streamline our work, making Syneos Health easier to work with and for.

    Join us to collaborate with passionate problem solvers and innovate 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 committed to developing our people through career progression, supportive management, technical and therapeutic training, and a total rewards program. Our Total Self culture encourages you to authentically be yourself, uniting us globally and ensuring everyone feels they belong.

    Job Responsibilities:

    • Perform site qualification, initiation, interim monitoring, site management activities, and close-out visits (on-site or remotely), ensuring compliance with regulatory, ICH-GCP, and Good Pharmacoepidemiology Practice (GPP) guidelines.
    • Verify that informed consent processes are adequately performed and documented for each subject.
    • Assess factors affecting patient safety and data integrity at investigator sites, including protocol deviations and pharmacovigilance issues.
    • Follow the Clinical Monitoring/Site Management Plan (CMP/SMP):
      • Assess site processes and conduct source document reviews.
      • Verify the accuracy and completeness of clinical data entered in case report forms (CRF).
      • Resolve queries remotely and on-site, providing necessary guidance to site staff.
      • Ensure site compliance with electronic data capture requirements.
    • Perform investigational product (IP) inventory, reconcile records, and verify proper administration according to protocol.
    • Review the Investigator Site File (ISF) for accuracy, reconciling with the Trial Master File (TMF).
    • Document activities through confirmation letters, trip reports, and communication logs, tracking all observations and action items.
    • Manage site-level activities to ensure project objectives and timelines are met.
    • Act as the primary liaison with study site personnel, ensuring compliance with training requirements.
    • Prepare for and attend Investigator Meetings and sponsor meetings.
    • Provide guidance for audit readiness and assist with preparations for audits.

    Qualifications:

    • Experience in the oncology therapeutic area.
    • Ability to travel within the UK and Ireland without restrictions.
    • Bachelor’s degree or RN in a related field, or equivalent combination of education 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.
    • Willingness to travel up to 75% regularly.

    Get to Know Syneos Health: Over the past five years, we have worked with 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.

    Additional Information: Tasks and responsibilities listed are not exhaustive. The company may assign other tasks and responsibilities as needed. Equivalent experience and skills will be considered. This job description does not constitute an employment contract.

    Syneos Health is committed to compliance with the Americans with Disabilities Act and will provide reasonable accommodations as necessary to assist employees or applicants in performing essential job functions.

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