Sr. Clinical Documentation Coordinator - Marlboro – Marlborough

Sr. Coordinator, Clinical Documentation
- Clinical Operations - Marlborough, MA

By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.

Boston Scientific is looking for a Sr. Coordinator for Clinical Documentation within the Clinical Operations Department. This is a corporate position located in Marlborough, MA.

This position supports the collection, maintenance, filing, and archiving of essential clinical study documentation (study master files) for Clinical Trials reporting to Clinical Operations. Management of documentation includes both paper and electronic files. Under supervision of the Clinical Documentation Manager, this position will provide support and participation for the implementation, maintenance, and continued improvement of physical and electronic documentation systems for the archiving of essential clinical study documents.

Duties include:

• Receiving, tracking, filing and archiving of essential documents produced for BSC Clinical Studies
  
• Liaise between in-house personnel and/or regional personnel within trials to ensure receipt of both BSC in-house and Investigator Site File Documentation
  
• Working in collaboration with clinical project teams to ensure that are processed in a timely manner
  
• Assist with routine quality control checks of the Study Master Files to ensure that study documentation is accurate, complete and accessible
  
• Provide back-room support during third party audits and inspections
  
• Assisting with implementation and upgrades to electronic systems for Document Management
  
  QUALIFICATIONS
  Education: Minimum four-year college degree, preferably in the life sciences
  Experience: Prefer 2-4 years experience with clinical trial documentation and clinical research experience including:
  
• Basic knowledge of ICH GCP Section 8
  
• Expertise in Microsoft Word, Microsoft XL, and other Microsoft Office Applications is essential, other database experience; experience working with document management systems or trial management systems is preferred
  Candidate should be detailed oriented with excellent organizational skills and ability to balance multiple projects across changing timelines. Excellent communications skills are essential. Must be able to lift 20 lbs.
  
  Apply Here