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    Sr Cra I

    Syneos Health
    0-1 years
    Not Disclosed
    Remote - Europe
    10 Nov. 29, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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 - Sponsor Dedicated

    Therapeutic Area: Immunology & Rare Disease
    Company: Syneos Health
    Location: Global

    About Syneos Health

    Syneos Health is a fully integrated biopharmaceutical solutions organization specializing in clinical, medical affairs, and commercial services. With a mission to accelerate customer success, the company focuses on innovation, collaboration, and the delivery of high-impact therapies.

    Job Summary

    The Senior Clinical Research Associate (CRA) is responsible for overseeing and conducting site qualification, initiation, monitoring, and close-out visits for immunology and rare disease studies. This sponsor-dedicated role ensures compliance with regulatory guidelines and project protocols while driving site-level activities from initiation to completion.

    Key Responsibilities

    Site Management & Monitoring

    • Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remote).
    • Assess site performance and compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol guidelines.
    • Oversee informed consent documentation, ensuring subject confidentiality and safety.
    • Identify and address protocol deviations, patient safety concerns, and data integrity issues.
    • Review and reconcile investigational product (IP) inventory, storage, and dispensing.
    • Conduct source document review and ensure accurate, timely entry of clinical data in case report forms (CRFs).
    • Manage electronic data capture requirements and resolve queries efficiently.

    Documentation & Reporting

    • Maintain accurate and timely documentation in Investigator Site Files (ISF) and Trial Master Files (TMF).
    • Ensure compliance with local archiving and regulatory requirements.
    • Prepare confirmation letters, follow-up letters, trip reports, and communication logs.

    Collaboration & Training

    • Act as a liaison between site staff and project teams to meet deliverables and timelines.
    • Support subject recruitment and retention strategies.
    • Train and mentor junior CRAs, and perform sign-off visits as assigned.
    • Lead or participate in Investigator and project staff meetings, audits, and training sessions.

    Specialized Tasks for Real World Late Phase (RWLP)

    • Develop country-specific informed consent forms and support regulatory submissions.
    • Collaborate with sponsors, medical science liaisons, and local staff to optimize study execution.
    • Perform chart abstraction activities and contribute to operational efficiencies.

    Qualifications

    Education & Experience

    • Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
    • Knowledge of ICH Guidelines, Good Clinical Practice, and applicable regulations.
    • Prior experience in immunology and rare disease studies preferred.

    Technical Skills

    • Proficiency in Microsoft Office Suite and electronic data capture systems.
    • Strong understanding of investigational product management and regulatory requirements.

    Soft Skills

    • Excellent communication, presentation, and interpersonal abilities.
    • Strong organizational and critical-thinking skills.
    • Ability to adapt to changing priorities and manage up to 75% travel.

    Why Join Syneos Health?

    • Meaningful Work: Collaborate on transformative therapies with a global impact.
    • Career Growth: Advance your career through training, mentorship, and cross-functional collaboration.
    • Diversity & Inclusion: Thrive in an environment that values authenticity and varied perspectives.

    How to Apply

    Take the initiative to shape the future of healthcare innovation. Apply now or join Syneos Health's Talent Network to stay connected with career opportunities.

    Syneos Health encourages diverse applicants, including those with transferable skills, to apply.

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