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    Clinical Research Associate Ii

    Caidya
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 4, 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, 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 Title: Clinical Research Associate II (Part-Time)
    Location: Homebased, Brazil

    Job Overview:
    This part-time contractor position (up to 0.5 FTE) involves monitoring investigational sites for an oncology study in Brazil. The Clinical Research Associate II (CRA II) is responsible for ensuring subject safety, conducting high-quality data review, and reporting in compliance with Caidya and/or client SOPs, Good Clinical Practice (GCP), ICH guidelines, ISO 14155, and other applicable regulations. The CRA II will build and manage site relationships while serving as a liaison between the Sponsor and assigned sites.

    Key Responsibilities:

    • Support the Project Team and Clinical Operations Team.
    • Maintain a working knowledge of study protocols and Monitoring Plans.
    • Serve as the primary contact for assigned research sites.
    • Conduct pre-study, initiation, interim monitoring, and close-out visits per the Monitoring Plan.
    • Ensure compliance with protocol requirements and applicable regulations.
    • Protect the rights and well-being of trial subjects.
    • Reconcile site regulatory binders and ensure the completeness of regulatory documents.
    • Assist with translations of essential documents as needed.
    • Support submissions to IRB/IEC and regulatory authorities.
    • Verify informed consent and eligibility of enrolled subjects.
    • Perform source data verification against Case Report Form entries.
    • Ensure accurate and complete data entry and documentation of corrections.
    • Conduct Investigational Product accountability, including inventory and record-keeping.
    • Monitor and report adverse events/serious adverse events.
    • Ensure sites have adequate project-specific supplies.
    • Communicate any protocol deviations to the investigator and project management team.
    • Deliver quality written trip reports and follow-up letters within SOP timelines.
    • Participate in team teleconferences and relevant trial meetings.
    • Engage in site audits as requested and conduct feasibility assessments.
    • Contribute to the development of monitoring guidelines and tools.
    • Uphold confidentiality agreements and identify potential fraud or misconduct.
    • Participate in improving current processes within the Caidya Quality Management System.
    • Accurately document time spent on projects in the Caidya time allocation system.
    • Demonstrate flexibility and proactively manage site issues.

    Supervisory Responsibilities:

    • None

    Job Requirements:

    Education:

    • Bachelor’s degree in healthcare or life sciences preferred.
    • Candidates with 2+ years of relevant clinical research experience in pharmaceutical or CRO industries will be considered in lieu of a degree.

    Experience:

    • Minimum of 1 year of on-site monitoring experience in clinical studies.

    Skills/Competencies:

    • Strong written and verbal communication skills.
    • Excellent interpersonal and monitoring skills for conducting site visits.
    • Good documentation skills with proficiency in English and the local language.
    • Proficient in Microsoft Office and computer skills.
    • Comprehensive knowledge of GCP/ICH guidelines and medical terminology.
    • Ability to exercise judgment within defined procedures and practices.
    • Attention to detail, problem-solving abilities, and strong organizational skills.
    • Capable of working in a matrix environment with effective time management.

    Capabilities:

    • Valid driver’s license and ability to drive, if applicable.
    • Valid passport required for international travel.
    • Willingness to travel up to 80%.

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