Job Title: Sponsor Dedicated CRA II/Sr CRA I - Home Based ITA
Company: Syneos Health
Location: Home-Based, Italy (Preference: Milan area)
Job ID: 25003314
Updated: April 23, 2025
About Syneos Health:
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by combining deep clinical, medical affairs, and commercial expertise. With a team of 29,000 employees in 110 countries, we center our work around both the customer and patient to improve outcomes in an ever-evolving market.
Why Join Us:
Career development and growth opportunities
Strong line management and peer recognition
Total rewards program
Inclusive and diverse “Total Self” culture
Job Role Overview:
As a Sponsor Dedicated CRA II/Sr CRA I, you will monitor and manage clinical trial sites to ensure protocol, ICH-GCP, and regulatory compliance. This is a home-based role requiring up to 75% travel, ideally based around the Milan area.
Key Responsibilities:
Conduct on-site and remote site qualification, initiation, monitoring, and close-out visits
Ensure proper documentation and compliance with informed consent processes
Identify, report, and escalate protocol deviations and patient safety issues
Perform source document verification and data accuracy checks
Guide and resolve queries with site staff
Support investigational product (IP) management including storage, dispensing, and accountability
Maintain and reconcile Investigator Site Files (ISF) and Trial Master Files (TMF)
Ensure audit readiness and assist with audit follow-ups
Enter site data in tracking systems and maintain comprehensive documentation
May serve as liaison with site personnel and lead CRA/project staff meetings
Provide training or mentorship to junior CRA staff
Additional Responsibilities (for Real World Late Phase - RWLP):
Support all phases from site identification to close-out
Execute chart abstraction and data collection
Develop country-specific informed consent forms
Collaborate with sponsor, medical liaisons, and RWLP Regulatory team
Attend bid defense meetings and suggest operational improvements
Required Qualifications:
Minimum of 2 years as certified CRA (as per D.M. 15 Nov 2011)
Sound knowledge of ICH-GCP and other relevant regulations
Proficient with digital tools and data systems
Excellent interpersonal, presentation, and communication skills
Ability to travel up to 75% as needed
Note:
This job description may evolve over time. Equivalent education, experience, or skills may be considered. Syneos Health is an equal opportunity employer committed to compliance with all applicable laws, including the Americans with Disabilities Act and EU Equality Directive.
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