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    Clinical Research Associate Fsp

    Novotech
    3+ years
    Not Disclosed
    Seoul
    10 July 19, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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: Clinical Research Associate (CRA)

    Company Overview:

    Novotech is a leading Asia-Pacific biotech specialist CRO, with expertise in clinical trials and drug development consulting services. We operate under two brands: Novotech and PPC. With over 3,700 clinical projects completed, including Phase I to Phase IV trials and bioequivalence studies, we are well-positioned to support biopharmaceutical clients globally. Our team consists of over 2,750 professionals across 11 geographies in Asia-Pacific, the United States, and the UK. Novotech is ISO 27001 and ISO 9001 certified, ensuring the highest IT security and quality standards.

    Position: Clinical Research Associate (CRA)
    Location: Multiple geographies
    Employment Type: Full-time

    Responsibilities:

    • Relationship Management: Build and maintain relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials.
    • Customer Relations: Foster internal and external relationships to ensure efficient, timely, and productive project delivery according to study requirements and timelines.
    • Documentation and Compliance: Collaborate with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA) to prepare site essential documents and support ethics and regulatory submission and approval processes.
    • Regulatory Understanding: Work with the Regulatory Start-up (RSU) Team to understand local and international regulatory requirements applicable to specific clinical trials.
    • Site Monitoring: Monitor investigational sites per ICH GCP §5.18 and the Clinical Monitoring Plan (CMP). Conduct various monitoring visits across all trial phases, including Site Selection, Site Initiation, Site Monitoring, and Site Close Out. Visits may be onsite or remote as per CMP.

    Minimum Qualifications & Experience:

    • Education: Graduate in a clinical or life sciences-related field. Relevant experience or qualifications in allied professions may also be considered.
    • Experience: At least 3 years of experience as a Clinical Research Associate in the clinical industry.
    • Skills: Good time management, attention to detail, teamwork, and computer literacy.

    What We Offer:

    • Work Environment: Flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development programs.
    • Diversity & Inclusion: We are committed to being an employer of choice for gender equality and providing an inclusive work environment. We welcome applications from LGBTIQ+ individuals, people with disabilities, and those with caring responsibilities.
    • Commitment: As a Circle Back Initiative Employer, we are dedicated to responding to every application.

    About Us:

    Novotech provides comprehensive clinical development services across all trial phases and therapeutic areas. Our services include feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, and project and vendor management.

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