Clinical Research Coordinator

Company: Katalyst Healthcares & Life Sciences
Location: Rockville
Posted on: February 22, 2021

Job Description:

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. 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:
      • 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) Additional Information All your information will be kept confidential according to EEO guidelines.

Keywords: Katalyst Healthcares & Life Sciences, Rockville , Clinical Research Coordinator, Healthcare , Rockville, Maryland