Clinical Research Associate II - Italy
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.
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.