Lead CRA

TN Italy; Italia; In loco; EUR 40.000 - 80.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Research Coordinator to oversee clinical studies and ensure compliance with protocols. The role involves organizing and supervising trials, maintaining communication with clinical sites, and supporting regulatory interactions. Ideal candidates will possess a Bachelor's Degree and have significant experience in clinical monitoring and medical devices. Join a dynamic team where your expertise will contribute to innovative healthcare solutions and enhance patient outcomes.

Competenze

• 5 years of experience in medical device or clinical roles.
• Experience in regulated industries and electronic data capture systems.

Mansioni

• Organize and supervise clinical studies, ensuring protocol compliance.
• Serve as primary contact for clinical sites and support interactions with regulatory authorities.

Conoscenze

Clinical Monitoring

Communication Skills

Problem-Solving

Regulatory Compliance

Data Review

Formazione

Bachelor's Degree in a related field

Associate's Degree or equivalent

Strumenti

MS Office

Electronic Data Capture Systems

Descrizione del lavoro

Job Responsibilities

1. Organize and supervise clinical studies, providing oversight and insights into trial activities such as protocol compliance, enrollment, monitoring deviations, and data quality. Communicate findings to principal investigators, support staff, study sponsors, and ethics committees.
2. Assist with clinical monitoring activities as needed.
3. Serve as the primary contact for assigned clinical sites, ensuring the achievement of clinical milestones and maintaining communication throughout the study process.
4. Support interactions with Ethics Committees and Regulatory Authorities.
5. Participate in project team meetings and collaborate with internal stakeholders to ensure proper project conduct.
6. Assist in training site personnel and Edwards staff, including preparing and maintaining study documents, completing forms, and understanding required examinations and assessments.
7. Report on site enrollment progress, device accountability, protocol deviations, and collect and audit Case Report Forms and supporting documentation.
8. Process adverse events and document procedural observations related to post-procedural events.
9. Conduct data review, safety reporting, and complaint handling.
10. Ensure compliance with regulatory and clinical protocols, including maintaining regulatory documents, reporting adverse events and device malfunctions timely, and managing device-related issues.
11. Develop and implement process improvements and deliver training on GCPs, protocols, database management, compliance, and other study-related activities.
12. Ensure audit readiness for internal and external audits.
13. Mentor new or junior staff members.
14. Perform other duties as assigned by management or Clinical Trial Leadership.

Education and Experience

• Bachelor's Degree in a related field with 5 years of relevant medical device or clinical experience, or
• Associate's Degree or equivalent with 7 years of field monitoring, quality assurance, and regulatory compliance experience.
• Experience working in a regulated industry and with electronic data capture systems.
• Clinician experience (e.g., RN, RT, ORT, RCIS) and experience in interventional cardiology or cardiothoracic surgery are preferred.
• Agile, dynamic, and solution-focused traits are preferred.

Additional Skills

• Proficiency in MS Office and general office machinery.
• Strong communication, presentation, and interpersonal skills, including negotiation and relationship management.
• Excellent problem-solving and critical thinking skills.
• Adherence to company rules, safety protocols, and environmental protections.