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    Cra Ii - Must Have Immuno-Inflammation (Dermatitis Atopic) Expereince - Sponsor Dedicated - Bulgaria

    Syneos Health
    2+ years
    Not Disclosed
    Bulgaria
    10 Nov. 26, 2024
    Job Description
    Job Type: Remote 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

    Clinical Research Associate II
    Company: Syneos Health
    Location: Global (extensive travel required, up to 75%)

    About Syneos Health

    Syneos Health is a global leader in biopharmaceutical solutions, driven to improve patient outcomes by blending clinical, medical, and commercial expertise. With over 29,000 employees across 110 countries, we are committed to accelerating the delivery of innovative therapies.

    Our collaborative culture focuses on bringing patients and customers to the forefront of everything we do, ensuring streamlined processes and impactful results.

    Why Join Syneos Health?

    • Empowered Growth: Comprehensive career development, therapeutic area training, and progression opportunities.
    • Inclusive Culture: Our Total Self initiative supports authenticity, diversity, and belonging.
    • Global Impact: Contribute to groundbreaking projects supporting 94% of FDA-approved drugs and 95% of EMA-authorized products in the past five years.

    Key Responsibilities

    Clinical Monitoring & Site Management

    • Conduct site qualification, initiation, interim, and close-out visits (on-site or remote).
    • Ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practices (GPP), and regulatory guidelines.
    • Review site performance, patient safety, and protocol adherence, escalating critical issues as needed.

    Data Review & Documentation

    • Verify accuracy of source documents and case report forms (CRFs).
    • Manage query resolution, guiding site staff toward timely completion.
    • Ensure site processes comply with electronic data capture requirements.

    Investigational Product (IP) Oversight

    • Monitor IP storage, reconciliation, and administration per protocol and regulatory standards.
    • Manage risks linked to blinded or randomized studies and ensure compliance with GCP/local regulations.

    Collaboration & Training

    • Act as the primary contact for study sites and sponsor affiliates.
    • Support audit preparation and provide guidance for audit readiness.
    • Train and mentor junior staff, fostering a knowledge-sharing environment.

    Real World Late Phase (RWL) Specific Duties

    • Oversee study lifecycles from site identification through close-out.
    • Collaborate with healthcare providers, sponsors, and local teams.
    • Conduct chart abstraction and data collection activities.

    Qualifications

    • Bachelor’s degree or RN in a related field (or equivalent combination of education and experience).
    • Strong knowledge of ICH/GCP Guidelines and regulatory frameworks.
    • Excellent technical skills with a readiness to embrace new technologies.
    • Superior communication, organizational, and interpersonal abilities.
    • Willingness to travel extensively (up to 75%).

    Additional Notes

    Syneos Health fosters an environment of innovation and inclusion. We are committed to equal opportunity, providing reasonable accommodations under the ADA where needed. Tasks and responsibilities may evolve to meet the needs of the organization, reflecting our dynamic and agile culture.

    Make your mark in an ever-evolving field. Join Syneos Health today.

    For more details and to apply, visit Syneos Health Careers.

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