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Clinical Trial Associate

Spring, TX

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Description

1. 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.
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2. 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.
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3. Provides administrative support to associate director of clinical operations includes
but is not limited to scheduling meetings and calls, preparing agendas, distributing
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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.
4. 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.

Job Requirements

• Bachelor’s degree in clinical or scientific discipline.
• At least two years clinical research experience or business environment required.
• Prior oncology research experience preferred.
• Proficiency with computer systems and Microsoft Office required.
Specialized Knowledge/Skills –
• Attention to detail, solid execution, strong interpersonal skills, and a team player.
Working Conditions:
Environment (Office, warehouse, etc.) –
• Traditional office environment
Physical Requirements (Lifting, standing, etc.) –
• Large percent of time performing computer based work is required.

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