Clinical Research Associate

1 settimana fa

Verona, Veneto, Italia Barrington James A tempo pieno

Freelance Clinical Research Associate (CRA) – Cardiology Medical Devices

12-Month Freelance Contract (Direct with Sponsor)

Location:
Italy (must be based in Italy)

Start Date:
ASAP

About the Role

We are seeking an experienced
Freelance Clinical Research Associate (CRA)
with a strong background in
cardiology medical devices
to support a high-priority clinical program. This role is contracted directly with the sponsor and focuses on accelerating
Study Start-Up (SSU)
activities, conducting
Site Initiation Visits (SIVs)
, and managing
Close-Out Visits
, along with routine monitoring responsibilities as needed.

Key Responsibilities

  • Act as the primary point of contact between study sites and the sponsor
  • Drive
    fast and efficient SSU activities
    , ensuring activation timelines are met
  • Conduct
    Site Initiation Visits (SIVs)
    and
    Close-Out Visits
    according to the study plan
  • Perform on-site or remote monitoring, ensuring compliance with the protocol, GCP, ISO 14155, and regulatory requirements
  • Verify source data, device accountability, safety reporting, and protocol adherence
  • Support site staff with troubleshooting and provide ongoing training related to the cardiology device
  • Maintain accurate and up-to-date study documentation and reports
  • Collaborate closely with the sponsor's clinical and regulatory teams to ensure alignment on study progress and site performance
  • Identify and escalate risks, deviations, or site issues promptly

Required Qualifications

  • Based in Italy
    with full ability to work as an independent freelancer
  • Minimum
    3–5 years CRA experience
    within medical device clinical research
  • Proven experience conducting SIVs and Close-Out Visits independently
  • Ability to manage multiple sites and timelines efficiently
  • Excellent communication skills in Italian and English
  • Strong organizational skills with the ability to support accelerated SSU timelines

Preferred Skills

  • Experience in early-phase or post-market cardiology device studies
  • Ability to work autonomously and proactively in a fast-moving environment

Why Join?

  • Direct contracting with an innovative sponsor
  • Opportunity to contribute to an important cardiology-focused clinical program
  • Flexible freelance arrangement with competitive rates
  • High visibility and impactful role in speeding up study activation

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