Clinical Research Associate Ii - Ophthamology - Italy

Job Overview: As a Senior CRA specializing in ophthalmology, you will play a crucial role in the planning, implementation, monitoring, and management of clinical trials related to ophthalmic drugs, devices, or therapies. You will ensure that clinical trials are conducted in accordance with applicable regulatory requirements, protocols, and standard operating procedures.

Responsibilities:

1. Clinical Trial Monitoring:

   • Conduct site initiation, routine monitoring, and close-out visits to ensure protocol compliance and data integrity.
   • Perform source document verification, review of case report forms, and data validation.
   • Monitor patient safety and report adverse events in adherence to regulatory guidelines.

2. Site Management:

   • Develop and maintain strong relationships with investigative sites, investigators, and study coordinators.
   • Provide training to site staff on protocol requirements, study procedures, and Good Clinical Practice (GCP) guidelines.

3. Protocol Adherence:

   • Ensure that the conduct of the clinical trial is in compliance with the approved protocol, regulatory requirements, and applicable SOPs.
   • Assist in the development and review of clinical trial protocols, informed consent forms, and other study-related documents.

4. Data Management:

   • Collaborate with data management teams to ensure accurate and timely data collection, cleaning, and database lock.
   • Review and resolve data discrepancies and ensure data quality.

5. Regulatory Compliance:

   • Assist in preparing and submitting regulatory documents to obtain necessary approvals.
   • Stay current with regulatory requirements and industry best practices.

6. Risk Management:

   • Identify potential risks and issues in the conduct of the clinical trial and implement appropriate corrective actions.
   • Ensure that the trial is conducted in accordance with the principles of ICH GCP and relevant regulations.

7. Team Collaboration:

   • Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and data management.
   • Provide mentoring and support to junior CRAs as needed.

Qualifications:

• Bachelor's degree in a relevant scientific field; advanced degree (Master's, PhD) is a plus.
• Several years of experience as a Clinical Research Associate, with a focus on ophthalmology trials.
• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements related to clinical trials.
• Strong communication and interpersonal skills.
• Ability to travel to investigative sites as required.