Lead Clinical Research Associate

Join to apply for the Lead Clinical Research Associate role at TFS HealthScience . LEAD CRA FREELANCE 0.5 FTE - REMOTE (ITALY) TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service‑capabilities, resourcing and functional service (FSP) solutions. Key Responsibilities Support the Project Manager and be responsible for overseeing all aspects of monitoring and site management activities, ensuring compliance with ICH/GCP guidelines, SOPs, and protocol requirements. Lead, manage and guide CRAs, responsible for training and quality oversight of site management activities while proactively identifying potential operational issues and ensuring study deliverables. Develop study monitor plans, site training plans, verification initiatives, coordinate investigator meetings, and review site and country study reports. Ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from feasibility through to close‑out. Serve as the initial point of contact for the monitoring team and support liaison with investigative site personnel. Implement monitoring/recruitment plans and support design of CRF completion guidelines. Perform co‑monitoring visits as part of the monitoring team’s quality oversight. Review and approve site visit reports (PSV, SIV, MV, COV) and act as the first point of contact for issue escalation, ensuring proper resolution and action‑plan definition and follow‑up. Review CRA site‑visit calendars, ensuring visits (both remote and on‑site) are scheduled and conducted per the monitoring plan frequency. Update the Project Manager on status of sites and countries and ensure proper escalation of any issues detected at site/country level. Ensure documents remain current during the trial and maintain the Trial Master File; perform QC when delegated by the Project Manager. When delegated by the Project Manager, track and approve investigator payments. Assist the Project Manager in the CRA training program, training CRAs on study procedures and requirements, and ensuring proper handover when a CRA is replaced. Qualifications Bachelor’s Degree, preferably in life science or nursing; or equivalent. Minimum 3 years of experience as a CRA, including relevant on‑site monitoring experience. Experience in Phase 4 / RWE / Non‑Interventional Studies. Experience in Oncology, ideally Breast Cancer. Understand the basic medical terminology and science associated with assigned drugs and therapeutic areas. Possess understanding of Good Clinical Practice regulations, ICH guidelines. Ability to work independently as well as in a team matrix organization and manage multiple projects. Excellent written and verbal communication skills, as well as computer skills. Excellent organizational and line‑management skills. Ability and willingness to travel up to 10–20%. What We Offer We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients. A Bit More About Us Our journey began over 27 years ago in Sweden, in the city of Lund. As a full‑service, global Contract Research Organization (CRO), we build solution‑driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light, serving as the framework for decision‑making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us toward our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference. Seniority level Mid‑Senior level Employment type Contract Job function Research, Analyst, and Information Technology Industries Pharmaceutical Manufacturing #J-18808-Ljbffr