Clinical Research Associate II - Italy at Linical

Linical; Milano; Ibrido; EUR 45.000 - 65.000; Tempo pieno

Vantaggi offerti da questo lavoro

Home-based flexibility

International trials

Team environment

Competitive package

Descrizione del lavoro

Linical Milano (Italy) is seeking a Clinical Research Associate II to oversee multiple investigative sites across Italy. This on-site role requires ensuring trials are conducted per study protocols, ICH-GCP, and regulatory standards, with significant travel and site management responsibilities.

The successful candidate will have a Life Sciences degree with CRA training, at least 4 years in clinical research and 2 years monitoring experience, and fluency in Italian with English proficiency.

Competenze

• Life Sciences degree or equivalent with recognised CRA training.
• Minimum 4 years' clinical research experience.
• Minimum 2 years' monitoring experience as a CRA.
• Strong knowledge of ICH-GCP, trial regulations, and site management.

Mansioni

• Conduct site qualification, initiation, monitoring and close-out visits.
• Ensure patient safety, data integrity and protocol compliance.
• Perform source data verification and review documentation.
• Manage site relationships and provide ongoing investigator support.
• Assist with ethics committee and regulatory submissions as required.
• Monitor investigational product accountability and site performance.
• Maintain Trial Master File (TMF) documentation and assist with queries.
• Collaborate with cross-functional study teams to deliver trials.

Conoscenze

Communication skills

Organisational skills

Problem-solving

Italian language

English language

Independent working

Travel readiness

Formazione

Life Sciences degree

CRA training

Descrizione del lavoro

Clinical Research Associate II - Italy at Linical in Milano, LOM, IT.

This Full time on site position offers great opportunities for career growth.

Are you an experienced Clinical Research Associate looking to join a dynamic and growing clinical research organisation?

We are seeking a CRA II to manage investigative sites across Italy, ensuring clinical trials are conducted in accordance with study protocols, ICH-GCP, and applicable regulatory requirements.

Key Responsibilities

• Conduct site qualification, initiation, monitoring, and close-out visits.
• Ensure patient safety, data integrity, and protocol compliance.
• Perform source data verification and review study documentation.
• Manage site relationships and provide ongoing support to investigators and study staff.
• Assist with ethics committee and regulatory submissions where required.
• Monitor investigational product accountability and site performance.
• Maintain Trial Master File (TMF) documentation and support query resolution.
• Collaborate with cross-functional study teams to ensure successful trial delivery.

About You

• Life Sciences degree or equivalent experience, plus recognised CRA training.
• Minimum 4 years' clinical research experience.
• Minimum 2 years' monitoring experience as a CRA.
• Strong knowledge of ICH-GCP, clinical trial regulations, and site management.
• Fluent in Italian with a good command of English.
• Excellent communication, organisation, and problem-solving skills.
• Ability to work independently and manage multiple priorities.
• Valid driver's licence and willingness to travel up to 75%.

What We Offer

• Home-based flexibility.
• Opportunity to work on international clinical trials.
• Collaborative and supportive team environment.
• Competitive salary and benefits package.