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Clinical Research Coordinator

Ironwood Pharmaceuticals, Inc.


Location:
Cambridge, Massachusetts
Date:
05/24/2017
2017-05-242017-06-23
Categories:
  • Clinical Operations
Ironwood Pharmaceuticals, Inc.
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Job Details

Position description:

We are seeking a motivated and enthusiastic entry level clinical research professional interested in joining our fast-paced company to support multiple clinical research studies. The primary responsibility of the Clinical Research Coordinator will be to maximize the operational efficiencies in Phase 1–4 clinical trials. The Clinical Research Coordinator will report to the Clinical Study Manager.

 

Responsibilities:

  • Collaborates closely with Ironwood Clinical Study Managers, study teams, and CRO partners;

  • Supports implementation and management of clinical research studies through file management and clinical project document control;

  • Assists the Ironwood clinical project teams in project related activities, such as creating study binders, shipping study documents, and drafting newsletters;

  • Reviews and tracks clinical trial regulatory documents;

  • Assists in the planning and preparation for investigator meetings;

  • Maintains study tracking tools and study calendars;

  • Works closely with Ironwood Records Management, Ironwood Regulatory, and CROs to ensure adequate clinical trial documentation;

  • Completes telephone logs, notes to file, and status reports;

  • Participates in study team meetings and drafts meeting minutes and agendas;

  • Some travel may be required.

 

Qualifications:

  • B.S. / M.S. or equivalent;

  • Internship(s) or equivalent entry level experience in clinical research at a hospital, CRO, or biopharmaceutical company is strongly preferred;

  • Superior understanding of Microsoft Office products;

  • Aptitude for organizational detail;

  • Capacity to complete tasks independently in a highly-regulated environment;

  • Flexibility to function well within a team environment and within condensed timelines;

  • Ability to verbalize complex study issues and demonstrated problem-solving ability;

  • Basic understanding or willingness to learn FDA regulatory requirements and good clinical practice (GCP).

Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.