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Clinical Studies Support Coord II
Ref No.: 18-11633
Location: Mounds View, Minnesota
Start Date / End Date: 09/24/2018 to 09/24/2019
Supports clinical studies by executing and maintaining one or more of the following areas.
• Creates and manages the clinical study files.
• Performs periodic audits of clinical study files and document tracking systems for completeness and actively drives completion of action items.
• Creates and manages site activation tracking systems.
• Tracks progress by ensuring receipt of proper study documentation, agreements, and site approvals.
• Conducts periodic quality checks to identify issues related audit readiness documents and tracks the resolution of any issues.
• Supports content generation of newsletters and is responsible for circulation.
• Provides electronic systems support to the clinical study team for archiving and tracking study documents.
• Supports compiling and filing source documents.
• Provide project support for clinical study teams and/or department
• Maintain study-specific correspondence and other required documentation
• Assist in the coordination of meetings and meeting logistics
• Assist in the organization and distribution of clinical study documentation
• Assist in tracking study activity, such as start-up progress by ensuring receipt of proper study documentation, agreements, and site approvals
• Work with clinical team to create and distribute newsletters and communications to sites
• Schedule and attend team meetings, taking notes on discussion points and action items. Distributes meeting minutes.
• Support daily projects where the use of Excel, Power Point, SCTMS, and RAD is required
• Solve problems of moderate scope and complexity following established policies and procedures
• Identifies issues in documents, memos, correspondence, and telephone calls which require action. Recommends alternatives and executes alternative when appropriate.
• Drafts brief project related documentation
• Perform various study duties including facilities coordination, project document organization and reconciliation, setting up files, ordering supplies/equipment, photocopying
• Works under general supervision
• Other duties as assigned

Must Have: Minimum Requirements

High school diploma
Minimum of 4-6 years of clinical study administration or related experience

Nice to Have
• Demonstrated expertise in medical or technical area
• Proficient knowledge in word processing, spreadsheets, and database applications (e.g., MS Word and Excel)
• Experience with Documentum RAD
• Experience with Siebel CTMS
• Experience with Oracle EDC
• Proficient knowledge of medical terminology
• Thorough knowledge of clinical and outcomes research study design
• Complete understanding of clinical processes, regulations and regulatory standards
• Proficiency with GCPs, regulatory and compliance guidelines for clinical trials
• General knowledge of other related disciplines (Regulatory, Marketing, Product Development)
• Advanced oral and written communication skills