Previous Job
Clinical Studies Support Coord II
Ref No.: 18-19761
Location: Santa Rosa, California
We are hiring two candidates for this role. One will sit in Santa Rosa, CA and the other will sit in Plymouth, MN.

The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. This group includes Aortic, Peripheral, and Venous (APV), Cardiac Rhythm and Heart Failure (CRHF), and Coronary and Structural Heart products.

Within CVG, the Aortic, Peripheral, and Venous (APV) Group offers treatment for vascular abdominal and thoracic aortic disease, interventional devices used to treat Peripheral Artery Disease (PAD) through catheter-based procedures and diagnostic technologies, as well as treatment for venous disease.

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