Upsilon Global are seeking a freelance CRA based in Italy to perform remote monitoring visits and site management activities across 5 sites for a cardiology study.
This is estimated to be 0.5 FTE, starting in October and working with an expanding CRO with operations across US, EU and APAC regions.
Regulatory and start-up activities have been performed and we now need a local expert to take over for the main monitoring activities.
Key Responsibilities
Conduct remote visits, monitoring and assessment of clinical trial site, ensuring adherence to study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements.
Perform source document verification, data collection, and accurate recording of study data, ensuring data integrity and compliance.
Collaborate with site investigators, site staff, and study team members to ensure successful execution of clinical trials.
Assist in the development and review of study documents, including protocols, informed consent forms, and case report forms.
Maintain effective communication with study site, sponsors, and other stakeholders to provide timely updates, address queries, and resolve issues.
Monitor subject safety, reporting adverse events, and ensuring appropriate follow-up actions are taken.
Contribute to the preparation and coordination of study initiation, monitoring, and close-out activities.
Assist in the preparation and participation in regulatory inspections and audits as necessary.
Stay updated with current regulations, guidelines, and industry trends related to clinical research in translational / early-phase trials.
Qualifications
5+ years independent monitoring experience.
A strong background in cardiology trials
In-depth knowledge of local regulatory requirements and clinical trial processes.
Strong organizational and communication skills, with the ability to manage multiple priorities.
Ability to work independently, demonstrating initiative, attention to detail, and problem-solving skills.
For more information, please apply via the link or contact applications@upsilonglobal.com
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