Sponsor Dedicated CRA II/ Sr CRA I – Home Based ITA

About This Opportunity

We are representing a confidential life sciences organization seeking a Sponsor Dedicated CRA II/Sr CRA I to join their team on a remote basis in Italy. Our client works with pharmaceutical innovators throughout the drug development continuum, and this role offers the opportunity to contribute to meaningful clinical research that advances patient care.

Responsibilities

• Perform site qualification, initiation, interim monitoring, management activities, and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP, and protocol compliance
• Evaluate overall site and site staff performance, provide recommendations for site-specific actions, and escalate serious issues to project teams with action plans
• Verify informed consent processes are adequately performed and documented; ensure subject/patient confidentiality is protected
• Conduct source document review of site source documents and medical records per the Clinical Monitoring/Site Management Plan
• Verify clinical data entered in case report forms is accurate and complete; apply query resolution techniques and drive closure within agreed timelines
• Perform investigational product inventory, reconciliation, and review storage/security; verify IP has been dispensed and administered according to protocol
• Review Investigator Site Files for accuracy, timeliness, and completeness; reconcile with Trial Master File contents
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
• Support subject/patient recruitment, retention, and awareness strategies
• Act as primary liaison with study site personnel; ensure all assigned sites and team members are trained and compliant
• Prepare for and attend Investigator Meetings and sponsor face-to-face meetings
• Provide guidance toward audit readiness standards and support audit preparation and follow-up actions
• For Real World Late Phase studies: provide site support throughout study lifecycle, perform chart abstraction activities, collaborate with medical science liaisons and local country staff

What We're Looking For

• 2+ years of experience as a Certified CRA according to M.D. 15 Nov 2011
• Previous experience with Oncology trials is required
• Strong knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements
• Excellent computer skills and ability to embrace new technologies
• Strong communication, presentation, and interpersonal skills
• Ability to manage required travel as per monitoring plan needs
• Home-based in Italy

How We Work With You

When you apply through Get A Job.ai, our recruiting team will review your qualifications and conduct an initial screening. If there's a strong match, we'll submit your profile to our client for consideration. Please note that you should not contact the client directly—all communication and coordination will flow through our talent team to ensure a smooth process for everyone involved.

Pay

Our client offers competitive compensation. Specific details will be discussed during the interview process.

Equal Opportunity

Get A Job.ai is committed to providing equal employment opportunities to all qualified applicants regardless of race, color, religion, sex, national origin, age, disability, or any other protected characteristic. We celebrate diversity and are dedicated to creating an inclusive environment for all employees.