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