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    Clinical Research Associate

    Fortrea
    2+ years
    Not Disclosed
    Mumbai
    10 May 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    JOB DESCRIPTION

    Organization: Fortrea

    Position: Clinical Research Associate (CRA)

    About Fortrea

    Overview:

    • Leading global contract research organization (CRO).
    • Provides a wide range of clinical development, patient access, and technology solutions.
    • Specializes in more than 20 therapeutic areas.
    • Operates with over 19,000 staff in more than 90 countries.
    • Committed to transforming drug and device development for partners and patients globally.

    Website: Fortrea

    Summary of Responsibilities

    • Site Management: Manage clinical studies according to Fortrea’s SOPs, ICH GCP Guidelines, project plans, and Sponsor requirements.
    • Site Monitoring: Conduct site monitoring for clinical trials, including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring, and Close-out Visits.
    • Project Planning: Prepare and implement project plans related to Clinical Monitoring responsibilities.
    • Subject Protection: Verify adherence to informed consent procedures, protocol requirements, and regulatory requirements.
    • Data Integrity: Review and verify source documents, generate and resolve queries, ensuring data integrity against established guidelines.
    • Regulatory Compliance: Ensure Site Regulatory documents and eTMF/Sponsor Documents are complete and current.
    • Investigational Product Management: Ensure accurate inventory and accountability of study materials, secure storage per protocol.
    • Quality Control: Adhere to global quality control and CRA performance metrics.
    • Audit Readiness: Ensure sites are audit-ready.
    • Leadership: Act as Lead CRA as assigned.

    Qualifications

    Education:

    • University or college degree, or certification in a related allied health profession (e.g., nursing licensure) from an accredited institution.
    • Equivalent experience may be substituted as appropriate.

    Knowledge:

    • Thorough understanding of ICH GCP Guidelines and local regulatory requirements.

    Experience

    • Minimum of 2 years of Clinical Monitoring experience.

    Fortrea’s Commitment

    Fortrea seeks motivated problem-solvers and creative thinkers to revolutionize the clinical trial development process. We are dedicated to delivering life-changing ideas and therapies swiftly to patients in need. Join our team and embrace a collaborative environment that nurtures personal growth and enables a meaningful global impact.

    Equal Opportunity Statement

    Fortrea is an Equal Opportunity Employer (EOE/AA), striving for diversity and inclusion. We do not tolerate harassment or discrimination of any kind and make employment decisions based on business needs and individual qualifications without regard to:

    • Race
    • Religion
    • Color
    • National origin
    • Gender (including pregnancy or other medical conditions/needs)
    • Family or parental status
    • Marital, civil union, or domestic partnership status
    • Sexual orientation
    • Gender identity
    • Gender expression
    • Personal appearance
    • Age
    • Veteran status
    • Disability
    • Genetic information
    • Any other legally protected characteristic

    Encouragement: We encourage all to apply.

    For more information, visit Fortrea.

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