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Alimentiv

Posted 6 months ago

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Join our Talent Pool - Clinical Research Associates (Eastern Europe)

BudapestRemoteFull-time

AI Summary

Join Alimentiv's talent pool for anticipated Clinical Research Associate roles (CRA I/II and Senior) in Budapest. Responsibilities include site management, remote and onsite monitoring visits, data and system reviews, query resolution, safety and adverse event follow-up, site startup support, TMF documentation, and mentoring junior CRAs.

About this role

Don't see an opening that quite matches what you're looking for, or not ready to make a move yet? Let us know!
We are proactively inviting qualified candidates to join our talent pool for anticipated Clinical Research Associate needs (across multiple seniority levels) to support our Clinical Monitoring team.

What the process looks like:

  • A Talent Acquisition representative will contact selected candidates to schedule a qualifying call to learn more about your experience, and what your timeline looks like
  • We'll also share details about timelines on our side - note that this Talent Pool is not necessarily for an immediate, active role
  • We'll keep your details on file and in mind - if an active vacancy does arise which matches your seniority and logistical details, we'll reach out to get an interview scheduled with the team

    • About the Role(s)

  • Clinical Research Associate I/II
  • Support/conduct (as appropriate) site management through remote and supervised onsite visits (initiation, monitoring, and close-out) in compliance with SOPs, protocol, and GCP.
  • Perform remote data and system reviews (EDC, CTMS, RBM, TMF) to ensure data quality, completeness, and regulatory compliance.
  • Assist/lead (as appropriate) with query resolution, safety reviews, and adverse event follow-up throughout the study lifecycle.
  • Support/conduct (as appropriate) site startup and activation activities, including investigator coordination, trial material delivery, and recruitment support.
  • Maintain accurate, timely, and complete TMF documentation, requesting updates as required.
  • Provide day-to-day operational support to Senior CRA, and Lead CRAs.
  • Participate in training, study meetings, and CRA development activities, building competencies required for role progression.
  • Sr. Clinical Research Associate
    • As above, with the addition of the following:
  • Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.
  • Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.
  • When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.
  • May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.
  • May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.
  • Oversee overall integrity of the study to promote positive working relationships with the site and staff.
  • Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.

    • Qualifications (may vary depending on role needs)

  • CRA I - minimum 1 year experience + Honours Bachelor Degree
  • CRA II - Minimum 2 years experience + Honours Bachelor Degree
  • Sr. CRA - Minimum 3 years experience + Honours Bachelor Degree

    • Compensation/Total Rewards

  • Compensation may vary depending on the role seniority, geographic location, and candidate experience.
  • All full-time, permanent roles will include a base salary + elgibility for performance-based bonus, as well as a variety of health, dental, RRSP matching, and more!
  • If contacted for an initial call, a member of our TA team will be happy to share more.

    • Skills

    Adverse Event Follow-upClinical MonitoringCo-monitoringCTMSEDCGCPInvestigator CoordinationMonitoring ReportsPatient RecruitmentQuery ResolutionRBMSite ManagementS&OPTMF

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