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    Clinical Research Associate Ii - Remote, Usa

    Advanced Clinic
    2+ years
    Not Disclosed
    Remote, USA
    10 Aug. 20, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

    Overview:
    The Clinical Research Associate (CRA) is responsible for monitoring clinical trials to ensure the accuracy, reliability, and quality of data collected at assigned sites. This role ensures compliance with study protocols, subject safety, data integrity, and confidentiality.

    Key Responsibilities:

    • Compliance & Monitoring:

      • Conduct site qualification, initiation, routine interim, and close-out visits in line with the Clinical Monitoring Plan (CMP).
      • Ensure studies adhere to approved Protocols, SOPs, CFR, Good Clinical Practice (ICH GCP), and local regulations.
      • Travel to sites as needed for monitoring and training.

    • Site & Study Management:

      • Participate in Investigator feasibility and site selection processes.
      • Verify site qualifications, ensure study staff training/certification, and manage protocol compliance.
      • Assist with site submissions to Independent Ethics Committees and Competent Authorities.

    • Data & Documentation:

      • Ensure data accuracy through source data review, document verification, and query resolution.
      • Maintain essential documents in Investigator Site Files and ensure timely data entry and resolution of queries.
      • Document visit findings and protocol deviations, and manage site action items and safety reporting.

    • Communication & Support:

      • Maintain positive relationships with site investigators and staff.
      • Provide study and protocol training to sites as needed.
      • Support study teams during internal audits and regulatory inspections.

    Experience Required:

    • Experience:

      • Minimum of 3 years in clinical research with at least 2 years of CRA field experience.
      • Study Coordinator experience is a plus.

    • Knowledge & Skills:

      • Strong understanding of FDA GCP-ICH Guidelines and local regulatory requirements.
      • Proficiency in Microsoft Office (Outlook, Excel, PowerPoint, SharePoint) and electronic systems (EDC, TMF, CTMS).
      • Excellent communication, organizational, and analytical skills.

    • Abilities:

      • Ability to work independently and as part of a team, manage non-responsive sites, and handle confidential information.
      • Ability to travel up to 80% of the time, including frequent overnight and air travel.

    Education:

    • Bachelor’s Degree or equivalent, preferably in Life Sciences or Nursing.

    Working Conditions & Physical Requirements:

    • Work Environment:
      • May require standing, walking, sitting, climbing, stooping, kneeling, crouching, talking, or hearing.
      • May involve lifting up to 25 pounds and exposure to various environmental conditions.
      • Frequent travel, including overnight and air travel, is required.

    Employer’s Rights:

    This job description is intended to provide a general overview of the responsibilities and requirements for the role. Duties may be adjusted as needed, and employment is at-will, meaning either the employee or the employer may terminate the relationship at any time. Reasonable accommodations may be made for individuals with disabilities to perform essential functions of the position.

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