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    Regulatory & Start Up Specialist I, Us Support, Cfsp

    Iqvia
    1-2 years
    Not Disclosed
    Mexico
    12 Nov. 23, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Description: Regulatory & Start-Up Specialist, cFSP - US Support

    Location:

    Mexico (Full Home-Based Role)

    Purpose:

    The Regulatory & Start-Up Specialist 1 (RSU Specialist) will drive and execute all start-up and maintenance-related activities and deliverables for assigned studies and sites within the US. This role is crucial in ensuring the timely and high-quality execution of site activation activities.

    Responsibilities:

    • Site Start-Up & Maintenance:

      • Ensure successful, on-time, and quality execution of start-up and maintenance activities for assigned sites and studies, primarily central IRB/EC sites.
      • Establish country/site activation plans and priorities in collaboration with CCOM/COM, Area SSU, CSM Lead, Contract Manager, and Regulatory Affairs teams.
      • Conduct risk assessments and develop mitigation plans with relevant teams to ensure smooth site activation.

    • Issue Identification & Resolution:

      • Proactively identify and communicate issues impacting site delivery and provide solutions to resolve them effectively.

    • Collaboration & Communication:

      • Attend regional/area start-up calls, contributing insights and updates for assigned sites and studies.
      • Work closely with the Regulatory and CTS teams to align on CA submission and approval status, ensuring consistency with other site activation requirements.

    • Essential Document Collection & Submission:

      • Collect essential documents from sites and perform quality checks (ALCOA).
      • Compile and submit ethics and other required local submissions, including customization of Informed Consent Forms (ICFs), patient-facing materials, and safety reporting.

    Qualifications:

    • Education:

      • Bachelor’s Degree required; a degree in health care or a scientific field is preferred.

    • Experience:

      • Minimum of 1-2 years of clinical research experience.
      • At least 1 year of experience in study start-up management, particularly supporting the US.

    • Skills:

      • Advanced proficiency in English (both written and spoken).
      • Strong analytical and critical thinking skills, with the ability to assess and address complex issues from multiple perspectives.
      • Excellent interpersonal skills, with the ability to build trust and communicate effectively with a wide range of stakeholders.
      • Ability to adapt to changing requirements and successfully manage multiple priorities in a fast-paced environment.

    This role offers the opportunity to apply your expertise in clinical research, regulatory submissions, and start-up management while collaborating with a global team to drive the successful activation of clinical sites across the US.

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