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    Senior Cra Ii - Must Have Early Phase Neurology Expereince - Sponsor Dedicated - Bulgaria (Homebased)

    Syneos Health
    2+ years
    Not Disclosed
    Bulgaria
    10 Nov. 23, 2024
    Job Description
    Job Type: Remote Education: RN/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

    Job Title: Senior Clinical Research Associate II

    Company: Syneos Health

    About Syneos Health

    Syneos Health® is a global biopharmaceutical solutions organization focused on accelerating customer success. Combining clinical, medical, and commercial expertise, we deliver results that adapt to the complexities of the modern healthcare landscape.

    With 29,000 employees operating in 110 countries, our Clinical Development model centers on customers and patients, ensuring agility and innovation in delivering life-changing therapies.

    Why Join Syneos Health?

    • Career Growth: Opportunities for professional development, technical training, and advancement.
    • Supportive Culture: Engaged leadership, peer recognition, and rewards programs.
    • Inclusive Environment: A Total Self Culture that fosters authenticity, belonging, and well-being.
    • Global Impact: Contribute to transformative research, backed by a diverse and collaborative team.

    Job Responsibilities

    Site Management & Monitoring

    • Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site and remote).
    • Ensure compliance with regulatory, ICH-GCP, Good Pharmacoepidemiology Practices (GPP), and protocol standards.
    • Assess site processes, staff performance, and compliance, escalating issues and creating action plans as necessary.
    • Verify informed consent processes and maintain patient confidentiality.
    • Monitor protocol adherence and assess factors affecting patient safety and data integrity.

    Clinical Data Oversight

    • Conduct Source Document Review (SDR) to ensure clinical data accuracy and completeness.
    • Resolve data queries, guiding site staff as needed to meet deadlines.
    • Verify compliance with electronic data capture (EDC) requirements.

    Investigational Product (IP) Management

    • Manage IP inventory, reconciliation, storage, and security.
    • Verify protocol-compliant IP dispensing and administration.
    • Ensure compliance with GCP/local regulations regarding IP handling and labeling.

    Documentation & Regulatory Compliance

    • Review and reconcile the Investigator Site File (ISF) and Trial Master File (TMF).
    • Document all activities, including trip reports, confirmation letters, and communication logs.
    • Support patient recruitment, retention, and site awareness strategies.

    Team Collaboration & Leadership

    • Act as a liaison with study site personnel, sponsors, and project teams.
    • Lead and participate in Investigator Meetings and global monitoring/project staff meetings.
    • Train, mentor, and supervise junior CRAs, conducting training and sign-off visits as needed.
    • Support audit readiness and follow-up actions.

    Real-World Late Phase (RWLP) Responsibilities

    • Provide site support throughout the study lifecycle, from initiation to close-out.
    • Participate in chart abstraction and data collection.
    • Develop study and country-level informed consent forms.
    • Collaborate with regulatory teams to ensure updated compliance information.
    • Identify process improvements and contribute to operational efficiencies.
    • Train junior staff and participate in bid defense meetings.
    • Provide input into Requests for Proposals (RFPs), site management strategy, and case report form (CRF) design.

    Qualifications

    Education & Experience

    • Bachelor’s degree in a related field or Registered Nurse (RN). Equivalent combinations of education and experience are considered.

    Knowledge & Skills

    • Proficiency in ICH-GCP Guidelines and applicable regulatory requirements.
    • Strong computer literacy and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Moderate critical thinking and problem-solving abilities.
    • Ability to travel up to 75% on a regular basis.

    Get to Know Syneos Health

    • Supported 94% of FDA-approved drugs and 95% of EMA-authorized products in the last five years.
    • Conducted 200+ studies across 73,000 sites involving 675,000+ trial participants.
    • Embrace a collaborative culture to challenge the status quo in a competitive environment.

    Additional Information

    • Responsibilities may vary based on project needs and organizational priorities.
    • Syneos Health complies with the Americans with Disabilities Act (ADA) and provides reasonable accommodations.
    • Equivalent qualifications and skills will be considered for all candidates.

    Learn more at Syneos Health.

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