Radius Health, Inc.

Clinical Trial Coordinator

US-MA-Waltham
4 weeks ago
Job ID
2017-1631
# of Openings
1
Category
Clinical Development

Overview

Seeking a motivated entry level clinical trial professional with the ability to support multiple clinical research studies in a fast-paced environment.

The Clinical Trial Coordinator supports the development programs for the investigational drug product candidate’s abaloparatide, RAD140 and/or RAD1901. The incumbent supports and assists project teams with all study related operational tasks.

Responsibilities

  • Collaborates closely will clinical operation study team leads and CROs as required
  • Collects, logs, tracks and files essential regulatory documents (TMF filing/coordinating) and facilitates QC activities of eTMFs.
  • Tracks and distributes study specific documents such as operational, pharmacy, and lab manuals to clinical research organization (CRO) and study sites if applicable.
  • Assists with the management and meeting coordination of the members of our data safety monitoring boards (DSMB) and clinical event committees (CEC).
  • Assists with preparing project status reports.
  • Contacts study team members and external vendors under the direction of the Clinical Team Leader.
  • Assists in the coordination of investigator meetings and studies presentation materials.
  • Maintains and schedules weekly team meetings and associated meeting agendas and minutes (draft, route for review, revise, distribute final to team and archive).
  • Supports other study related administrative tasks (scanning, emailing, filing, shipping, etc.).
  • Assists team members with travel accommodations, scheduling and expense reports.

Qualifications

  • 1-2 years of clinical operations experience in a pharmaceutical, CRO or hospital research setting.
  • Requires a BS degree or equivalent work experience in lieu of a degree.
  • Superior understanding of Microsoft Office products.
  • Experience working with essential regulatory documents and specifically trial master file organization (DIA reference model) and structure required.
  • Flexibility to function independently as well as within a team environment
  • Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required.

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