Clinical Research Associate – Italy

Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya’s vision is to achieve new advances in the field of healthcare and expertise in research development. Our goal is to help our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together and to become the clinical research leader in Europe.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique projects.

To learn more about us, visit www.excelya.com.

Excelya is currently seeking a Clinical Research Associate (CRA) in Italy, for a part-time, freelancing position. The CRA will be responsible for visiting sites based in Milano, Monza, Bergamo and Cagliari.

The role:

The Clinical Research Associate (CRA) is responsible for ensuring that the conduct of a clinical trial at selected investigational sites is according to the currently approved protocol/amendments, ICH-Good Clinical Practice guidelines, the Standard Operating Procedures (SOPs) and the applicable laws and regulations. Among his/her responsibilities, the most important ones are to ensure that the subject’s rights are respected and that all collected clinical trial data are accurate, complete and verifiable from source documents.

Job responsibilities:

• Contributes to the selection of potential investigators.
• Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management principles.
• Actively participates in Local Study Team meetings.
• Drives performance at the sites. Proactively identifies and ensures timely resolution of study-related issues.
• Manages study supplies, drug supplies and drug accountability at study site.
• Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan.
• Performs Source Data Review, Case Report Form review and Source Data Verification, in accordance with the Monitoring Plan.
• Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study.
• Ensures data query resolution in a timely manner.
• Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc) are available and ready for final archiving and completion of local part of the eTMF.
• Dependent on level of experience you may assist in training and mentoring less experienced CRA’s and taking on additional local project management responsibilities and tasks.