Clinical Research Associate

7 giorni 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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