Clinical Research Professional
4 settimane fa
PSI CRO is a leading Contract Research Organization with over 28 years of experience in the industry. We strive to deliver high-quality and on-time services across various therapeutic indications.
Job OverviewWe are seeking an experienced Clinical Research Associate II to join our team in Italy. This role involves monitoring tasks, working on clinical studies, and maintaining the highest quality standards in the industry.
Key Responsibilities- Monitoring Visits: Conduct and report onsite monitoring visits, ensuring compliance with regulatory requirements.
- Study Startup: Participate in study startup activities, ensuring timely initiation and completion.
- CRF Review and Query Resolution: Review Case Report Forms, verify source documents, and resolve queries in a timely manner.
- Site Communication and Management: Maintain effective communication with sites, manage site relationships, and ensure seamless collaboration.
- Vendor and Support Services: Serve as a point of contact for internal project teams, vendors, and support services.
- Study Progress Communication: Regularly update internal project teams on study progress.
- Feasibility Research: Participate in feasibility research to identify potential issues and develop mitigation strategies.
- Regulatory Support: Assist the regulatory team in preparing documents for study submissions.
- Audits and Inspections: Prepare for and participate in audits and inspections to ensure compliance.
- Education: University/College degree in Life Sciences or equivalent combination of education, training, and experience.
- Experience: At least 2 years of independent onsite monitoring experience in Italy, with expertise in Phase II and/or III monitoring visits.
- Therapeutic Areas: Experience in Oncology/Gastroenterology therapeutic areas is highly desirable.
- Languages: Full working proficiency in English and Italian.
- Software Skills: Proficiency in MS Office applications.
- Soft Skills: Ability to plan, multitask, and work in a dynamic team environment, with strong communication, collaboration, and problem-solving skills.
- Travel: Willingness to travel.
As a Clinical Research Associate II at PSI CRO, you will have opportunities to work on various projects, expand your knowledge of different therapeutic areas, and develop your skills in a supportive and collaborative environment. You will also enjoy a competitive salary and benefits package.
Salary EstimateThe estimated annual salary for this position is €60,000 - €80,000, depending on experience and qualifications.
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