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Clinical Trial Assistant

San Francisco, CA 94080

Posted: 09/21/2023 Employment Type: Contract To Hire Job Category: Clinical Development and Operations Job Number: 585906 Pay Rate: 45.00 Is job remote?: Yes Country: United States

Job Description

As a Clinical Trial Assistant (CTA) in Clinical Operations, you will be responsible for supporting the study team to ensure the execution of assigned trials according to the study timelines and in compliance with ICH GCP, country regulations, and SOPs. You will assume the eTMF Business Administrative responsibilities in support of the implementation, maintenance, business administration of clinical systems and document management activities across the development organization.  As a Document Specialist, you will be responsible for managing the electronic documents across various systems including, but not limited to, SharePoint, Microsoft Teams, electronic Trial Master File (eTMF) systems and Regulatory Information Management Systems (RIMS).  You will also be responsible for supporting the clinical study team to ensure the execution of assigned trials according to the study timelines. This role will provide you with the opportunity to expand your knowledge and experience in clinical research and management of clinical trials.
This is a six-month remote contract assignment offering approximately 30-40 hours per week of work.  Independent contractors not represented through an agency will be paid through our partner, Eastridge Workforce Solutions. 
The clinical operations team is based at our corporate headquarters in South San Francisco, CA; however, this contract opportunity is open to a remote engagement.

Primary responsibilities will include:
  • Clinical Trial Assistant
    • Reviews protocol/amendment for discrepancies and administrative edits (QC review).
    • Prepares/updates study documents related to protocol/amendment.
    • Supports the planning, conduct, management, and completion of assigned clinical trials under guidance.
    • Schedules meetings and performs related activities.
    • Coordinates study team communications, documentation, and correspondence.
    • Follows study timeline to meet deadlines for assigned tasks.
    • Tracks study-related information and provides accurate and up-to-date information and study status reports to the clinical team members.
    • Assists in Clinical Operations activities including, but not limited to, review study plans/manuals and other essentials documents.
    • Coordinates new vendor set-up in systems with Finance and Legal and manages purchase order creation and approval.
    • Requests Clinical Trial Insurance and guidance from Legal.
    • Tracks training requirements and training completion status for study specific team training.
    • Cultivates and maintain excellent working relationships with study vendors, including Contract Research Organizations (CROs).
    • May perform UAT of systems, such as the CRF in EDC.
    • Supports system access and helpdesk activities.
    • Manages submissions and updates of trial information in clinical trial registries.

  • eTMF Business System Administration / Document Specialist
    • Reviews, tracks, and files essential documents in the eTMF and RIMS such as informed consent documents, RA & IRB approvals, financial disclosure forms, and other study related documents for the study team.
    • Organizes and maintains file sharing spaces (SharePoint, Microsoft Teams) for the study team.
    • Lead the implementation, maintenance, business administration, testing, and upgrade of clinical systems including the  eTMF (specifically Veeva Vault).
    • Provide training and support for the company and CRO personnel for eTMF and related processes.
    • Ensure personnel are appropriately assigned eTMF user roles and permissions.
    • Lead eTMF transfers/migrations; preparation of documents and loading files, verification, tracking, documentation and archiving.
    • Maintain and review quality of data in the eTMF.
    • Leads development and oversight of data/metrics for TMF inspection readiness.
    • Supports other inspection readiness & compliance activities.? 

Qualified Contractors should have experience that includes:  
  • Bachelor’s degree preferred, but not required.
  • Previous experience in a Clinical Operations support role preferred.
  • Knowledge of clinical trial processes and ICH GCP guidelines.
  • Previous experience with eTMF Business Administration, document management and electronic filing systems, specifically Veeva Vault.
  • Experience filing essential documents according to the DIA Reference Model.
  • Ability to setup and manage file sharing spaces and associated user’s access.
  • Experience with leading document migrations, completing reconciliation and deleting duplicate documents.
  • Implementing standard conventions and taxonomies, metadata, and keywords to content, as needed.
  • Ability to multi-task, prioritize, track projects, and follow-through on-time with assigned tasks.
  • Ability to learn quickly and effectively using newly acquired skills.
  • Proven strong computer skills, including strong literacy with Microsoft Word, Excel, PowerPoint and Outlook.
  • Clear and concise verbal and written communication skills.
  • Ability to work independently and in a matrix environment as part of a team.
  • Strong organizational skills, ability to manage multiple tasks and meticulous attention to detail.
  • Demonstrated problem detection and problem resolution skills.
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