Research Associate

2 settimane fa

Verona, 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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