Senior Clinical Research Associate

Upsilon Global; Roma; Remoto; EUR 30.000 - 50.000; Part-time

Descrizione del lavoro

A leading clinical research organization is seeking a freelance CRA based in Italy to manage remote monitoring visits and site activities for a cardiology study. The role requires extensive experience in monitoring and knowledge of regulatory compliance, ensuring the integrity of clinical trials. The ideal candidate will have a strong background in cardiology trials and excellent communication skills for effective collaboration. This position offers flexibility and the opportunity to work with a global team.

Competenze

• 5+ years independent monitoring experience.
• A strong background in cardiology trials.
• In-depth knowledge of local regulatory requirements and clinical trial processes.
• Ability to work independently with attention to detail.

Mansioni

• Conduct remote visits and monitoring of clinical trial sites.
• Perform source document verification and data collection.
• Collaborate with site investigators and staff for successful clinical trials.
• Maintain effective communication with stakeholders and monitor subject safety.
• Assist in regulatory inspections and audits.

Conoscenze

Clinical trial monitoring

GCP guidelines

Regulatory compliance

Communication skills

Organizational skills

Problem-solving skills

Descrizione del lavoro

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 [e-mail]