Research Operations - Toronto - ClinSurge Research

    ClinSurge Research
    ClinSurge Research Toronto

    6 days ago

    Full time
    Description

    This position function will oversee operations and quality at GTA sites (Hamilton, Mississauga,Toronto, Scarborough), as well as provide backup CRC support (with focus on Toronto and Scarborough). Additionally, this position will operationally support growth projects, ie. opening of new locations, implementation of tech systems, initiationof new therapeuticarea.

    CRP supervision and training:

    Support with interviewing and hiring of CRPs across GTA locations

    Personnel management of CRCs(3-4)and RAs(1)across GTA locations, including regular 1:1 and group meetings

    Coordinate and conduct training sessions to support growth and development of CRPs

    Quality management & process refinement:

    Review IMV follow up letters and coordinate action based on trends detected

    Oversee the CAPA process for all identified MPDs

    Conduct internal audits as needed

    Prepare for and lead the conduct and response to external audits and inspections

    Own company-wide adherence to SOPs and GCP guidelines; continually refine and develop the set of SOPs,formsand source templates

    Support with source document creation and quality check, where needed

    Operations oversight:

    Oversee CTMS visit tracking and scheduling across all sites

    Regularly run CTMS reports to oversee operations trends and support in evaluation of CRP performance

    Have a pulse oneISFand coordinateclean-upefforts where necessary

    Identifyareas of operational or quality risk and coordinate with leadership on plan of action

    Support in study builds within CTMS, where needed

    Backup CRC and lab support:

    Support where operationally necessary as a backup CRC/lab tech, with focus on Toronto and Scarborough locations

    Investigator relationship management:

    Regularlytouch basewith PI's and SI's across all sites, incorporating their feedback into our workflows and ensuring frictionless research referrals

    Support in the engagement of potential new research investigators, including onboarding them to research through basic training elements

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