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Clinical Research Coordinator

Job Description

Job description:

  • The Immuno-Oncology (IO) Clinical Project Coordinator is a member of the Immuno-Oncology Global Medicines (GMD) group.
  • The IO Project Coordinator will work with a cross-functional team of experts to develop and maintain a web portal, database and robust process for the Toxicity Management Guidelines (TMGs) used across the IO Program.
  • The individual in this role will liaise with IO project teams, the IO Lead Safety Physician, IT, external vendors, colleagues from the Site Management & Monitoring (SM&M) organization, and external investigational sites across the world. This role could be broadened in future to include other IO processes.

Responsibilities:

  • Work with IT to develop the website, associated applications and training materials that will be used by IO project teams and external investigators
  • Maintain the database
  • Add/remove investigator sites and maintain information on who has access to web portal
  • Grant accesses to the portal based on IRB and Regulatory approval dates
  • Develop communication plan and ensure it is followed
  • Work collaboratively with key stakeholders such as IT, SM&M, and external vendors to identify a robust process for communicating changes in the database
  • Link with the IO Lead Safety Physician and other key stakeholders to ensure proper exchange of information and a common understanding of expectations
  • Develop and maintain the process, perform gap analyses and propose process improvements

Requirements:

  • Education Undergraduate degree
  • General knowledge of the drug development process
  • Database/process management experience in complex, multi-disciplinary environment
  • Experience of working collaboratively in global, multi-cultural teams
  • Proven ability to transition between roles effectively and learn rapidly in a new environment
  • Experience of building processes and conducting gap analyses
  • Experience in using databases and process maintenance
  • Experience of using CTMS databases (eg IMPACT)

Clinical Research Coordinator

Katalysthealthcareslifesciences
Rockville, MD
Full Time

Published on 01/14/2022

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