lavori in località Bari (Italia)

Work mode: Remote in Country

Location: in the area of Milan, on a remote-based working schedule.

About The Role

The Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO’s mission of building a world-class shared clinical technology, process innovation and clinical operations team, in partnership with company’s divisions, through technology enablement, high-touch customer service, study acceleration, and high-quality data collection.

Driving principles and behaviors for this role are: collaboration, accountability, innovation, adaptability, integrity, and caring.

In all actions, the CRA demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures. The CRA monitors the progress of clinical studies at the site level to verify that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP, and other applicable regulatory requirements. The CRA also provides support in enrollment, follow-up, and closure of clinical trial activities through collaboration with Trial Operations, Regulatory Affairs, and the Contract & Budget teams, as well as with divisional and regional clinical teams.

In this role, you will be responsible for:

• Source Verification: Conducts a comparison of data recorded on Case Report Forms against source documents, verifies Informed Consent Forms for accuracy and completeness, reviews regulatory documents and device accountability records.
• Communications: Ensures clear written communication to clinical sites and project team members through monitoring reports, follow-up letters, study memos, and general correspondence. Escalates serious issues as per company’s escalation process when appropriate.
• Training: Ensures all site personnel are appropriately trained and prepared to conduct the clinical study in accordance with protocol and applicable regulations. Monitors and maintains site personnel list, qualification, and training records.
• Compliance: Ensures compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WIs, policies & procedures. Ensures any identified site non-compliance issues are addressed, clearly communicated, documented, and escalated as required through monitoring visits, analyzing study metrics, and general study data overview. Supports internal quality audits and regulatory inspections, as required.
• Event Reporting: Ensures that all reportable events are identified, clearly documented, and reported per protocol and per applicable requirements and regulations.
• Collaboration: Participates in study-specific meetings, teleconferences, and training. Collaborates with cross-functional team members and study sites throughout all study phases.
• Documentation: Manages study request/collection of relevant (i.e. regulatory documents) investigator/site documentation.
• Study maintenance: Updates and maintains study-specific monitoring milestones in Clinical Trial Management Systems.

What are we looking for in you:

• Bachelor’s Degree, or an equivalent combination of experience and education.
• Fluency in Italian and English (written and spoken); any additional European language (Spanish) is a nice-to-have.
• Research Coordinator or Clinical Research Associate experience.
• Experience in Clinical Field Monitoring.
• Any experience working with CTMS (Clinical Trial Management Systems) or Electronic Data Capture systems is welcomed.
• Good organizational skills.
• Comfortable interacting with clinical research site personnel.
• Ability to work in a team.
• Ability to multitask: support several studies and/or personnel simultaneously.
• Ability to work in a very fast-paced and dynamic environment.
• Comfortable traveling up to 80% of the time, mainly in Italy, but not excluding short travels abroad.
• Driving license.

What we can offer you:

• Possibility to make an impact.
• Fast-growing and innovative environment.
• A team-oriented company culture.
• International opportunities.

We, Boston Scientific, are an equal employment opportunity employer. We do not and will not make any personnel decisions (like recruiting, hiring, job assignments, and promotions) based on a person’s age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state, or local law.