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Clinical Trials Associate

Parexel International Corporation

Southeast, Remote, United States of America

The Clinical Trials Associate is responsible for assisting clinical study teams in the execution of clinical trials and on-time delivery of clinical trial milestones.

Primary Responsibilities:

  • Establishes and maintains the Trial Master File (eTMF) in inspection-ready state
    • May communicate with sites to drive collection and review of essential documents throughout the study
    • Ensures accurate and timely review and filing of clinical trial related materials
    • Assists with Quality Control (QC) reviews of study, country, and site files, including issue resolution
    • Produces reports and status metrics as requested
  • Establishes and maintains the Clinical Trial Management System (CTMS)
    • Maintains accurate and up-to-date site, vendor, and internal study team contact information
    • Tracks study progress and produces reports and status metrics as requested
    • Assists with Investigational Product reconciliation activities
  • Assists study team by performing administrative tasks as needed
    • Schedules meetings, either onsite or remote by means of virtual conferencing system
    • Prepares meeting agendas, minutes, and track action items
    • Operates and navigates within clinical trial systems including but not limited to Electronic Data Capture (EDC), SharePoint Online, eTMF and CTMS
  • May assist with the creation and maintenance of documents and plans for assigned clinical studies, including but not limited to training materials, study binders, plans, presentations, and reports
    • Ensures timely distribution of clinical trial related materials
  • Assists in activities associated with company-sponsored site quality audits as well as regulatory authority inspections
  • Works under general supervision in performing regular job duties and receives general instructions on new assignments
  • Assists in vendor oversight and vendor contact management
  • Performs all duties and responsibilities in accordance with the Code of Federal Regulations (CFR), Good Clinical Practice/International Council of Harmonization (GCP/ICH) Guidelines, Standard Operation Procedures (SOPs), and other applicable guidelines
  • Completes assigned training, including general training requirements, Policies, SOPs, system, and process-related training
  • Demonstrates commitment to Parexel’s FSP Mission, Vision, and Values, and Parexel’s “We Care” Core Values

Education and Certification:

  • Bachelor of Science/Arts (BS/BA) or equivalent preferred, or relevant and qualifying training/experience

Skills and Experience:

  • A minimum of 1-year clinical operations experience, preferably within the pharmaceutical or biotechnology industry (global experience preferred)
  • Basic knowledge and understanding of Essential Documents, CFR and/or GCP/ICH
  • Proficiency with technological systems (Microsoft Office-Excel, PowerPoint, SharePoint Online, eTMF and CTMS (Veeva Vault Clinical preferred), EDC (Electronic Data Capture), Zoom, OneNote)
  • Fundamental understanding of filing systems and organizational tools

Language Skills:

  • Proficiency in written and spoken English
  • Proficient in local language, as applicable

Other Requirements:

  • This position may involve travel to Client for training or study needs, as applicable

Job posted: 2023-03-16