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    Sr Cra I

    Syneos Health
    2+ years
    Not Disclosed
    Remote Korea
    10 Dec. 1, 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

    The Senior Clinical Research Associate I (Sr CRA I) position at Syneos Health is a dynamic role focused on managing clinical sites, ensuring compliance with regulations, and supporting the progression of clinical trials. This position allows for remote work based in South Korea (KOR), and involves responsibilities across the lifecycle of clinical studies.

    Position Overview

    Location: Home-Based, South Korea
    Updated: November 27, 2024
    Job ID: 24006464

    As a Senior CRA I, you'll manage site monitoring activities, ensure adherence to regulatory guidelines, and support clinical trial progress from site qualification to close-out. The role requires a balance of technical, regulatory, and communication skills to ensure high-quality data capture and regulatory compliance across multiple sites.

    Key Responsibilities

    1. Site Monitoring and Management:

      • Perform site qualification, initiation, monitoring, and close-out visits, both on-site and remotely.
      • Ensure compliance with ICH-GCP, local regulations, and trial protocols.
      • Identify and escalate site-specific issues, proposing action plans.
      • Monitor patient safety and data integrity by assessing protocol deviations and pharmacovigilance issues.

    2. Data Integrity and Documentation:

      • Verify accuracy and completeness of clinical data entered into Case Report Forms (CRFs).
      • Review and resolve data queries, ensuring proper documentation and compliance with protocol and regulatory guidelines.
      • Oversee Investigational Product (IP) handling, inventory management, and ensure accurate dispensing.

    3. Collaboration and Communication:

      • Serve as a primary liaison with project site personnel, maintaining effective communication.
      • Collaborate with the project team to manage site activities, timelines, and deliverables.
      • Support subject recruitment and retention efforts, ensuring timely data entry into tracking systems.

    4. Training and Mentorship:

      • Provide mentorship and training to junior CRAs, including performing sign-off visits.
      • Ensure all site team members are trained and compliant with clinical requirements.

    5. Audit and Compliance:

      • Support preparation for audits and ensure audit readiness standards are met.
      • Document activities and track ongoing project status, maintaining all required documentation.

    6. Late Phase Real World Studies:

      • For Real World Late Phase (RWLP) studies, contribute to site identification, regulatory compliance, and data collection efforts.
      • Collaborate with other departments to support the real-world study design and local regulatory requirements.

    Qualifications

    • Education:

      • Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.

    • Experience:

      • Knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
      • Prior experience in site management and clinical monitoring.
      • Strong computer skills and ability to adopt new technologies.
      • Ability to travel up to 75% regularly.

    • Skills:

      • Strong communication, presentation, and interpersonal skills.
      • Basic critical thinking and problem-solving skills.
      • Ability to manage time and prioritize effectively in a dynamic environment.

    Why Syneos Health?

    • Culture:
      Syneos Health promotes a Total Self culture where you can authentically be yourself. The company is committed to inclusivity, career development, and global collaboration.

    • Impact:
      With a track record of working on 94% of all FDA-approved novel drugs and 95% of EMA authorized products, Syneos Health continues to play a vital role in advancing clinical trials globally.

    Application Information

    The Sr CRA I role offers an opportunity to take on significant responsibility in clinical trials while contributing to innovative therapies. If you meet the qualifications and are eager to be part of a globally recognized organization, Syneos Health encourages you to apply.

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