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Clinical Studies Support Coordinator
Ref No.: 18-43330
Location: Santa Rosa, California
Start Date / End Date: 09/04/2018 to 09/04/2020
Company: Artech Information Systems
Job ID: 18-43330
Job Title: Clinical Studies Support Coordinator
Location: Santa Rosa, CA
Duration: 24+ months
 
Job Description:
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
 
Thanks
Rajiv Maruthi
Rajiv.maruthi@artech.com