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Clinical Trial Coordinator II Job

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Date: Feb 23, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

About the role:

The Clinical Trial Coordinator performs administrative tasks as part of Clinical Project Process and work with clinical project teams and Clinical Research Associates/Field Clinical Research Engineers to support the completion of clinical trial documentation processes, budgets, contracts and device management (if applicable).

 

Your responsibilities will include:

  • Completion of Study Master File Index (SMFI).
  • Coordinate all translations.
  • Documentation - Receive and process (upload, assigning of attributes, filing, review and approval of subset of documents in CDC) required regulatory, legal and financial documentation in order to ensure successful study start-up (e.g. site initiation visits, product shipment, start of patient enrolment) and GCP study conduct throughout the study, following WI.  Manage study and site document archives (paper and/or electronic) as required.
  • Receipt of core trial documents from all clinical functions and file in accordance with SMFI.
  • Assembly & distribution of mass communications (MOP, Study Tools, Newsletters, Annual Reports).
  • Reconcile site training files.  Monitor and report project-specific training compliance.
  • Manage site/contact/study information on appropriate tool.
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.

 

What we’re looking for in you:

Minimum Qualifications

  • AA Degree or equivalent work experience in related discipline
  • 3 years of related experience, 1+ years relevant clinical experience required

Preferred Qualifications

  • Bachelor degree preferred
  • Strong verbal and written communication skills
  • Demonstrated ability to maintain and develop clinical study master files for ongoing and new clinical studies

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 475530

 


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