Freelance Clinical Research Associate Lazio

Freelance Clinical Research Associate
Roma
Lazio, Lazio

For our activities at Johnson & Johnson, we are looking for a Clinical Research Associate in Italy (sites to be further determined and will be discussed for your availability) to work on a freelance basis for approximately 0. 2 to 0. 6 FTE (to be determined based on the selected sites). In this assignment, you will work for J&J via Randstad Professionals. As a CRA for Johnson & Johnson, you'll be at the forefront of innovation, playing a crucial role in the development and delivery of life-changing medical devices. You'll be part of a collaborative and passionate team committed to advancing healthcare and improving patient outcomes. As a CRA, your primary tasks will be to manage: Ongoing Ethics Committee and/or Regulatory Authority communication Interim Monitoring Visits (on-site and remote) Close-out Visits Investigator site management and communication Sponsor communication Sponsor training You will have contact with clinical trial leaders, and the project will be monitored by the CRA resource manager of Johnson & Johnson. Essential knowledge and skills: 5 years clinical monitoring experience Experience of performing main monitoring visit types (Site Qualification, Site Initiation, Interim Monitoring Close Out) Education: minimum Bachelor's degree (within Life Science field) Medical device monitoring experience essential for this assignment Conducting clinical trials: You are experienced with managing and overseeing all aspects of clinical trials for a range of medical devices, ensuring compliance with regulatory guidelines and ethical principles. Monitoring study sites: You are experienced in visiting investigational sites, assessing data quality, ensuring patient safety, and fostering strong relationships with investigators and site personnel. Data collection and analysis: You're experienced in playing a vital role in the collection, verification, and analysis of clinical trial data, contributing to the development of robust evidence for regulatory submissions. Collaborating with cross-functional teams: You've worked closely with other professionals, including medical doctors, statisticians, and regulatory experts, to ensure the successful execution and completion of clinical trials. How to put your application forward? We will select incoming applicants based on job fit and experience. If you are selected, Randstad Professionals will invite you to a first interview to discuss your experience and expectations. The next step would be an interview with the CRA Resource Manager of J&J. Apply online with your resume, motivation, and rate indication. A letter of recommendation from a previous CRA, preferably with medtech experience, is a plus. A first shortlisting will be held soon. Seniority level Mid-Senior level Employment type Part-time Job function Administrative, Project Management, and Quality Assurance Industries Pharmaceutical Manufacturing and Biotechnology Research J-18808-Ljbffr