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.
Skills Required
- Life Sciences degree or equivalent experience
- Recognised CRA training
- Minimum 4 years of clinical research experience
- Minimum 2 years of CRA monitoring experience
- Strong knowledge of ICH-GCP
- Strong knowledge of clinical trial regulations and site management
- Fluency in Italian
- Good command of English
- Excellent communication, organisation, and problem-solving skills
- Ability to work independently and manage multiple priorities
- Valid driver's licence
- Willingness to travel up to 75%
What We Do
Linical is a global Contract Research Organization (CRO) that provides a full spectrum of drug development services, from early-phase research to large-scale, multinational clinical trials. Headquartered in Japan, the company supports pharmaceutical and biotech clients with services including clinical trial management, regulatory consulting, and pharmacovigilance. Linical is committed to high-quality, patient-centered research, leveraging its global network to help bring innovative new therapies to patients worldwide.
