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Clinical Research Site Director

Company: The Judge Group
Location: Brookline
Posted on: November 25, 2022

Job Description:

Location: Brookline, MA
Salary: 125000
Description: Our client is currently seeking a Clinical Research Site Director in Brookline, MA. - -This is an FTE/Salaried opportunity requesting of a hybrid work structure (in-office) Hiring Focus: -

  • ICH-GCP Certification and IATA Certification, or ability/willingness to attain. -
  • Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents and assigned study protocol(s). -
  • Responsible for immediate supervision and performance of the assigned site staff. -
  • Completing all the relevant training prior to study-start and on a continued basis in a timely manner. -Role Duties:
    • Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate as well as timely follow up on the action items, at their respective sites. -
    • Making sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study related documents are utilized and implemented at all times for the assigned protocol(s) at their respective site(s). -
    • Working with the Regulatory Team to ensure maintenance of Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their as for their assigned protocol(s) at their respective site(s) -
    • Working with the cross functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV. -
    • Ensuring clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents. -
    • Responsible for providing guidance to the site team on planning and monitoring the conduct of the clinical trials. -
    • Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectations -Experience and Skill Requirements: -
      • Minimum of 8-years experience in Clinical Research. -
      • 5 years Experience Managing Multiple Clinical Trials -
      • Experience Managing Teams
        Contact:
        This job and many more are available through The Judge Group. Find us on the web at

Keywords: The Judge Group, Brookline , Clinical Research Site Director, Executive , Brookline, Massachusetts

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