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    Cra Ii / Senior Cra - Sponsor Dedicated - Bulgaria

    Syneos Health
    2+ years
    Not Disclosed
    Bulgaria
    10 Nov. 23, 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

    Job Title: Clinical Research Associate II / Senior Clinical Research Associate

    Company: Syneos Health

    About Syneos Health

    Syneos Health® is a global, fully integrated biopharmaceutical solutions organization designed to accelerate customer success. We leverage clinical, medical, and commercial insights to address modern market challenges and deliver impactful results.

    With 29,000 employees in 110 countries, Syneos Health puts the customer and patient at the center of everything we do. Our collaborative and innovative approach simplifies processes, making us a preferred partner for customers and a rewarding place to work for employees.

    Why Work at Syneos Health

    • Career Development: We offer growth opportunities, peer recognition, technical training, and engaged line management.
    • Supportive Culture: Our Total Self culture ensures you can authentically be yourself, fostering belonging and inclusivity.
    • Global Impact: Collaborate with a diverse team to bring life-changing therapies to patients worldwide.

    Job Responsibilities

    Site Management & Monitoring

    • Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote) to ensure compliance with:
      • Regulatory requirements, ICH-GCP, and Good Pharmacoepidemiology Practice (GPP) standards.
      • Clinical Monitoring Plan (CMP) and Site Management Plan (SMP).
    • Evaluate site and staff performance, escalating issues and implementing action plans when necessary.
    • Verify informed consent processes and maintain patient confidentiality.
    • Monitor protocol adherence and assess site processes for compliance.

    Clinical Data Review

    • Perform source document review to verify clinical data accuracy and completeness.
    • Resolve data queries and guide site staff on query resolution.
    • Verify site compliance with electronic data capture (EDC) systems.

    Investigational Product Oversight

    • Manage investigational product (IP) inventory, reconciliation, storage, and security.
    • Ensure IP is dispensed and administered per protocol, adhering to blinding/randomization procedures.

    Regulatory & Documentation Compliance

    • Review and reconcile the Investigator Site File (ISF) and Trial Master File (TMF).
    • Ensure essential documents meet archiving requirements per local regulations.
    • Maintain accurate records via trip reports, confirmation/follow-up letters, and communication logs.

    Project & Team Collaboration

    • Act as primary liaison with site personnel and contribute to project deliverables.
    • Attend Investigator Meetings and sponsor face-to-face meetings.
    • Participate in global monitoring/project staff meetings and clinical training sessions.
    • Support subject recruitment and retention efforts.
    • Train junior staff and guide site teams on audit readiness.

    Real-World Late Phase Studies

    • Provide site support from initiation to close-out.
    • Conduct chart abstraction and data collection.
    • Collaborate with sponsor affiliates, medical science liaisons, and local staff.
    • Suggest potential sites based on local treatment patterns and HCP networks.

    Qualifications

    Education & Experience

    • Bachelor’s degree in a related field (e.g., life sciences) or Registered Nurse (RN).
    • Equivalent education, training, and experience may be considered.

    Knowledge & Skills

    • Strong understanding of ICH-GCP Guidelines and applicable regulatory requirements.
    • Proficiency with technology and willingness to adopt new systems.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage travel requirements of up to 75%.

    Get to Know Syneos Health

    • Collaborated on 94% of all Novel FDA-Approved Drugs and 95% of EMA Authorized Products over the past 5 years.
    • Conducted over 200 studies across 73,000 sites with 675,000+ trial patients.
    • Syneos Health provides a competitive and ever-evolving work environment that fosters initiative and innovation.

    Additional Information

    This job description is not exhaustive. Syneos Health reserves the right to assign other tasks or modify the role as needed. We value compliance with local legislation and commit to providing reasonable accommodations under the Americans with Disabilities Act.

    Note: Equivalent experience, education, and qualifications may be considered for candidates who do not meet all specified requirements.

    Learn more: Syneos Health Website

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