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    Clinical Trial Associate

    Caidya
    0-2 years
    Not Disclosed
    Remote, USA
    10 Nov. 4, 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 Title: Clinical Trial Associate
    Location: Raleigh, NC

    Job Overview:
    The Clinical Trial Associate (CTA) supports all phases of clinical studies in collaboration with global internal and external study team members. Under departmental and study team supervision, the CTA performs various administrative functions, including minute-taking, data entry, tracking, scanning, binder creation, and supply distribution. Responsibilities also include participating in study meetings, reviewing essential documents, and processing the Trial Master File (TMF). The role may involve budget negotiation, fee tracking, and amendment processing across multiple studies, meeting defined chargeability expectations.

    Key Responsibilities:

    • Attend internal and external meetings, providing updates and taking minutes as needed.
    • Support regulatory inspections and audits as required.
    • Interface with vendors as necessary.
    • Procure, maintain, and ship study documents, supplies, and materials in compliance with Caidya SOPs and study-specific processes.
    • Maintain study servers and portals as applicable.
    • Track documents and study status in relevant tracking systems.
    • Regularly report document collection and tracking issues to the functional lead or study team.
    • Identify, manage, and escalate site issues effectively.
    • Assist with ad hoc issue resolution as delegated.
    • Communicate functional area study status and provide associated reports to the study team.
    • Submit documents/files within the TMF and support document review and query resolution.
    • Regularly support site-level document collection via Clinical Research Associate (CRA) or directly from sites as requested.
    • Conduct completeness reviews of assigned TMF content and support the final site-level TMF review.
    • Assist the study team with TMF functionality and adherence to the study-specific TMF Plan.
    • Review and maintain study Outlook folders and correspond with sites, sponsors, and study team members as needed.
    • Perform other study-specific duties as assigned by the Project Manager and departmental management.
    • Conduct fee tracking and data entry as needed.
    • Assist with amendment tasks, including site notification, supply shipment, budget updates, and IRB submissions.
    • Support safety letter distribution to sites and the IRB as required.

    Supervisory Responsibilities:

    • None

    Job Requirements:

    Education:

    • College/university graduate preferred; a degree in healthcare or life sciences is a plus.
    • Equivalent combinations of education and relevant work experience will be considered.

    Experience:

    • Prior relevant work experience preferred.

    Skills/Competencies:

    • Strong written and verbal communication skills in English.
    • Excellent interpersonal skills and a team-oriented approach.
    • Proficient computer skills, including Microsoft Office.
    • Interest in learning medical terminology.
    • Exceptional attention to detail and highly organized.
    • Ability to work in a dynamic, changing environment.
    • Demonstrates honesty, trust, fairness, cooperation, self-control, and flexibility.

    Capabilities:

    • Ability to perform minor lifting (less than 30 lbs).
    • Must work from a regional office location.

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