Coordinator III, Clin Research - 200177 - Fremont, CA - 0100 – Fremont

Responsibilities:
The Senior Trial Coordinator will support clinical research executing all administrative aspects of study management from start-up through closeout. Responsible for assisting and providing support to the members of the clinical project team (i.e., Clinical Research Associates and Project Managers), in order to facilitate the management of pre-approval and post-approval clinical trial processes.

Duties and Responsibilities:

• Under minimal direction of clinical project management, performs clinical trial activities for ongoing clinical trials (local or global) including, status report generation, payment processing and maintenance of: device and regulatory document tracking systems, patient and Case Report Form (CRF) files, required regulatory documents, and central files.
  
• Coordinates device-handling processes including setting up SAP for clinical trial shipments, initiating shipments and returns, tracking inventory at sites and assisting with device reconciliation.
  
• Assists with archiving study documents for completed clinical trials.
  
• Assists with distribution, collection and tracking of regulatory documents (e.g., confidentiality disclosures, IRB approvals, and financial disclosures) to/from study sites.
  
• Uses CTMS database (or equivalent) to maintain site addresses, coordinate site payments, track device inventory, track clinical documents, and patient follow-up schedule and visit status.
  
• Coordinates subject enrollment-tracking system and prepare reports for project team.
  
• Coordinates with the BSC Legal Department to draft investigator agreements and contracts.
  
• Assists with preparation of reports (PMA, annual reports, etc.), and technical or scientific publications, as required.
  
• When necessary, assists with the organization of Investigator Meetings. Provide administrative support for Investigator Meetings and Annual Society meetings, including compilation of binder materials, overseeing presentations and scheduling activities.
  
• Assists with preparation of Clinical Events Committee (CEC) packets for CEC adjudication meetings.
  
• Provides training and mentoring for less experienced trial coordinators.
  
• May recommend process improvements to increase team efficiencies and effectiveness.
  
• Demonstrates working knowledge of clinical research conduct, laws, regulations, and standards, and complies with applicable BSC SOP's and policies.
  
• Distributes, collects, and tracks large amounts of documentation accurately and within project timelines.
  
  Minimum Education & Experience:
  Candidates with strong administrative background, Bachelor-level degree (or equivalent) preferred or minimum 3+ years clinical research experience. Experience in a related field (e.g. medical or research) and/or familiarity with medical terminology preferred.
  
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