Clinical Trial Associate

  • Location
    Woodland , Texas
  • Category
    Medical & Science - Administration
  • Job type

POSITION: Clinical Trial Associate
LOCATION: Woodlands, TX
DURATION: 7 months
PAY: 24.64 / hr

Position Summary
Under minimum supervision, performs a broad range of specific and essential departmental responsibilities to support the clinical operations team and research disease programs; is responsible for creating and launching site identification surveys for network studies; plans, collects, screens, and summarizes information gathered from clinical trials. Responsible for closing out research studies ensuring necessary documentation and payments have been completed. Provides administrative support to research disease programs. Works in compliance with principles of Good Clinical Practice and applicable federal, state, and local regulations. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards.

- Perform essential support for clinical research throughout all stages of a project; Tracks trial metrics such as patient enrollment, study training, deliverables, study deviation, and practice participation data including data backlog ensuring data is complete and accurate. Identify and resolve issues. Prepares progress reports and performance metrics for trial management to review. Creates, Modifies, maintains, and distributes study forms and tools to research sites including but not limited to protocol specific flow sheets, clinical trial information sheets, and training documentation. Monitors trial progress for compliance with regulatory and budgetary requirements; may be responsible for management of related documentation. Files and tracks study monitoring follow up letters for open protocols. (30%)
- Responsible for project management for non-treatment studies such as registries and studies closed to enrollment as assigned. Prepares and submits annual reports for the Institutional Review Board (IRB) on closed to enrollment or follow-up studies. Works with internal departments to ensure all paperwork and payments are completed in order to close a study. Prepares and administers materials to close out studies that have met all requirements. (20%)
- Provides administrative support to associate director of clinical operations includes but is not limited to scheduling meetings and calls, preparing agendas, distributing materials for disease program meeting. Manages study voting post program review. Retrieves, consolidates, and analyzes data and presents reports to associate director of clinical operations to use in supporting operational and business objectives. Enters new study information into various databases. Generates reports from various databases to support program management needs. Develops and maintains department manuals, forms, documents, and reference materials. (20%)
- Creates site identification surveys for all phase II– IV protocols within the US Oncology Research Network by reviewing protocol document, sponsor feasibility questionnaires, and details provided by the associate director of clinical operations and clinical trial manager. Works closely with the associate director of clinical operations to analyze available data from CTMS, iKnowMed, and other available sources to understand site study needs and patient population. Works closely with the clinical trial manager and network operations manager to identify potential sites to survey based on analysis of available data. Maintains site identification survey calendar in order to provide sites visibility of upcoming surveys. (20%)
- Other duties as assigned (5%)

Education/Training –
• Bachelor’s degree in clinical or scientific discipline.
• Approximately 1-3 years of clinical research experience or applicable business environment required.
• Prior oncology research experience preferred.
• Proficiency with computer systems and Microsoft Office required.
• Attention to detail, solid execution, strong interpersonal skills, and a team player.

Work Schedule
8am - 5pm, M-F

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Reference number US_EN_2_022862_397907