Clinical Research Associate

Pivotal is excited to expand our team and we are looking for an experienced, highly motivated Clinical Research Associate who shares our vision of providing clinical research excellence. Joining Pivotal as a CRA / SCRA means that you’ll enjoy being a member of one of the leading full-service contract research organizations in Europe with a very solid reputation. This role promises to gain direct experience with our clients and offer career growth and professional development within a scientific and data-driven company. You’ll have the opportunity to put your passion to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.

Why Pivotal

• We are passionate and fully committed to medical science while using technology to make a positive impact.
• We provide an exceptional experience, taking care of our employees with mentoring, training, and international opportunities for growth.
• We value diversity of thoughts, backgrounds, and cultures, creating an inclusive environment where everyone belongs.

Responsibilities

1. Be part of multi-national project teams, delivering excellent customer service across multiple studies.
2. Perform site selection, initiation, monitoring, and close-out visits.
3. Collaborate with the Regulatory team to obtain ethics and health authority approvals.
4. Evaluate site practices for compliance with GCP, ICH, and local regulations, providing recommendations based on judgment and experience.
5. Immediately communicate and escalate serious issues, developing action plans.
6. Manage site progress, including recruitment, eCRF completion, and data queries.
7. Participate in problem-solving and risk mitigation strategies.
8. Collaborate with study site experts and client representatives.
9. Maintain knowledge of relevant regulations and SOPs.
10. Protect subject confidentiality and maintain study files.

Requirements

• Degree in life sciences or related field, or healthcare apprenticeship.
• Minimum two years of on-site monitoring experience or equivalent.
• Knowledge of GCP and ICH guidelines.
• Flexibility to travel 6-8 visits per month.

Skills

• Problem-solving skills, attention to detail, and organizational ability under time pressures.
• Strong communication skills in English and Italian.
• Autonomous work capability.
• Proficiency in MS Office.

What to Expect

• Resources for career growth.
• Supportive leadership and flexible schedules.
• Training to expand therapeutic knowledge.
• Dynamic work environment with new experiences.

Equal Opportunity

At Pivotal, we believe diversity and inclusion are key to our success. We are committed to providing equal employment opportunities to all candidates regardless of race, gender, sexual orientation, disability, or other characteristics.