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    Clinical Operations Lead - Perth, Australia - Alimentiv Inc.

    Alimentiv Inc.
    Alimentiv Inc. Perth, Australia

    1 week ago

    Default job background
    Full time
    Description
    Responsible for the clinical operations of a projectwithin a defined regional/global level.

    Provides oversight of project deliverables, assigned Clinical ResearchAssociate (CRAs) and Investigator sites in accordance with the MonitoringPlan, Protocol, Good Clinical Practice (GCP), ICH guidelines and localregulations.

    The COL acts as a primary liaison between the CRAs and theclinical project team.

    Additionalresponsibilities include project specific training of CRAs, conductingassessment visits with CRAs, implementation of enrollment and recruitmentstrategies, preparation of the monitoring plan and other structuraldocumentation and the oversight of monitoring visit scheduling, site andmonitoring performance metrics, issue escalation and corrective actions.

    The COL will develop study tools for siteand CRA use, review visit reports, review and track protocol deviations, andsupport other objectives for clinical operations and the clinical project team.

    Project OversightOverall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.

    Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.

    May support clinical project team by providing oversight of study deliverables related to other departments (e.g.
    Data Management, TMF Operations, etc.)
    Oversee regional startup and feasibility activities.
    Assist in vendor management activities as required per project.
    Perform review of visit reports for quality, compliance and appropriate site management.
    Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.

    Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.

    Contribute to financial project management processes as applicable.
    May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.
    May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.
    Project LiaisonConduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls
    Attend meetings with Study Sponsor to provide status updates on country and site progress
    Provide operational support and guidance to the monitoring team throughout project.
    Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study.
    Ensures study specific training requirements are completed and documented.
    First point of contact for regional CRAs for study-specific questions and issues.
    Escalates to PM and other functions as appropriate.
    Support line managers by providing status updates on utilization and performance of CRAs.

    Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.

    Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.
    Study Documents and PlansDevelop training materials and study tools for sites and CRAs, including monitoring plans.
    Develop and implement enrolment and recruitment strategies together with clinical project team.

    Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.

    QualificationsCollege diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading
    ORUndergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training
    OtherHealth Sciences, Life Sciences or Nursing specialty preferred, or So CRA and/or ACRP Certification/Designation.

    Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.


    Demonstrate the following attributes:
    proactive, detail oriented, task-driven and highly organized.
    Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.
    Demonstrated ability in report writing and strong ability to critically understand clinical research documents.
    Ability to handle multiple tasks to meet deadlines in a dynamic environment.
    Working ConditionsHome-based

    Accommodations for persons with disabilities are available on request in respect of all aspects of the recruitment and selection lifecycle.

    Requests can be directed to


    PHISHING SCAM WARNING:

    Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media.

    Please note that Alimentiv only uses company email addresses, which contain "", to communicate with candidates via email.

    If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender's email address and that they are asking you to apply on this website.

    If you believe you've been a victim of a phishing scam, please contact your local government cyber authority to report.

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