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    Senior Clinical Research Associate

    Insight Global
    4+ years
    Not Disclosed
    Remote
    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

    Position Overview:

    The Senior Clinical Research Associate (Sr. CRA) role offers an exciting opportunity for career growth within an emerging medical device company. We are seeking a candidate with solid knowledge of clinical study processes, including adherence to Good Clinical Practice (GCP)/ICH guidelines and the Code of Federal Regulations. The Sr. CRA will have a mix of in-house and fieldwork responsibilities and will collaborate closely with the CRA Manager, Project Manager(s), and Clinical Project Team to support various aspects of clinical trials and related regulatory activities.

    Key Responsibilities:

    • Site Visits and Monitoring:

      • Conduct site qualification, initiation, monitoring, and closeout visits, and document findings through accurate and detailed visit reports.
      • Verify completeness and accuracy of source documents and electronic data capture (EDC) by reviewing subject records and source documentation. Ensure all subjects meet inclusion/exclusion criteria.
      • Review source records for patient safety and ensure thorough documentation of safety events.
      • Ensure regulatory binder is complete, accurate, and up-to-date at the site.

    • Site and Study Management:

      • Ensure compliance with study protocols and clinical objectives.
      • Train site personnel on study procedures and document training. Confirm that site staff are qualified and trained to perform their tasks.
      • Support investigator involvement and IRB/EC oversight.
      • Address and resolve issues of significance, including informed consent and IRB submission processes as needed.

    • Site Coordination and Support:

      • Work closely with Project Manager to review or draft study documents such as Clinical Monitoring Plans and Informed Consent Templates.
      • Manage site recruitment and enrollment challenges, ensure timely data entry and query resolution, and address follow-up challenges.
      • Monitor site submission of safety event documents and collaborate with coordinators for timely reporting. Ensure all information is available for DSMB reporting.
      • Participate in site calls and support CAPA identification and resolution.

    • Regulatory Master File (RMF) Management:

      • Organize and maintain site study files and regulatory documentation.
      • Collaborate with other CRAs to ensure consistency between RMF and site files, and maintain accurate records of essential study materials.
      • Ensure timely and proper filing of study documents in accordance with SOPs and regulatory standards.

    Qualifications:

    • Education and Experience:

      • Bachelor’s degree in a life sciences field or related discipline; familiarity with medical terminology is preferred. Experience in Neuroscience or medical device studies is a plus.
      • Minimum of 4 years’ experience in clinical research with a strong understanding of clinical study documentation and GCP/ICH guidelines.
      • Proficiency in Microsoft Office (Word, Excel, PowerPoint) and familiarity with EDC systems.

    • Skills and Attributes:

      • Proven ability to build and maintain relationships with clinical sites and colleagues. Experience in mentoring junior CRAs and audit experience is preferred.
      • Ability to manage multiple projects simultaneously with attention to detail and flexibility.
      • Strong independent work ethic with excellent time management skills.
      • Willingness to travel up to 50%, including international travel (US, Canada, Europe, Israel, and Asia). Candidates should reside in the US with easy access to travel options.

    Join our dynamic team and contribute to advancing clinical research in a growing medical device company. Apply today to be a key player in our innovative and collaborative environment.

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