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    Clinical Research Associate Fsp

    Novotech
    1-3 years
    Not Disclosed
    Indore
    10 July 19, 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, 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 extensive experience in clinical trials and drug development consulting. With over 2,750 FTEs across 11 geographies, Novotech offers clinical development services across all phases and therapeutic areas. We are committed to an inclusive work environment, gender equality, and providing flexible working options, wellness programs, and ongoing development opportunities.

    Position: Clinical Research Associate (CRA)
    Location: [Location not specified]
    Experience: Minimum 3 years in Clinical Research

    Primary Responsibilities:

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

    Minimum Qualifications & Experience:

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

    Company Benefits:

    • Inclusive Environment: Commitment to being an employer of choice for gender equality and providing a fair and respectful work environment.
    • Flexible Work Options: Support for flexible working, paid parental leave for both parents, flexible leave entitlements, and wellness programs.
    • Diversity: Open to individuals who identify as LGBTIQ+, have a disability, or have caring responsibilities.
    • Professional Development: Ongoing development programs and support for team members.

    About Novotech:

    • Expertise: Over 3,700 clinical projects, including Phase I to IV trials and bioequivalence studies.
    • Global Presence: Offices in Asia-Pacific, the United States, and the UK with site partnerships at key medical institutions.
    • Certification: ISO 27001 for Information Security Management System and ISO 9001 for Quality Management.

    Commitment: Novotech is a Circle Back Initiative Employer and commits to responding to every application.

    We look forward to your application and the opportunity to work together in advancing clinical research and biotechnology.

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