Clinical Research Associate

Obsessed by Science. Entrepreneurial by Nature. United by Purpose. Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions. As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios. When you join Diasorin, you are not just filling a role. You are helping build what comes next. Why Join Diasorin Build What Matters – Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide. Innovate with Agility at a Global Scale – Work in an entrepreneurial environment that enables speed, collaboration, and global impact. Grow in a People-Centered Culture – Thrive in a culture that values accountability, inclusion, and continuous development. Job Scope The Clinicial Research Associate will be responsible for conducting day-to-day work associated with analytical and clinical studies conducted by Luminex, A DiaSorin Company for inclusion in regulatory submissions for in vitro diagnostic devices. Planning and execution of in-house clinical studies as well as training and monitoring of external clinical sites. Key Duties And Responsibilities Day-to-day “hands on” work associated with in-house clinical studies. Identify, qualify, initiate, monitor and close out investigational sites for clinical studies; prepare accurate and timely visit reports from all site visits; review and finalize visit reports. Ensure studies are carried out according to the study protocol, standard operating procedures (SOPs), and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) regulations and study specific manuals and procedures. Develop and maintain good working relationships with Principal Investigators and Study Staff. Track and report on progress of studies including site activation, subject enrollment, and monitoring visits. Create clinical study document designs and tracking tools. Investigate queries, monitor discrepancies, and manage investigational device accountability and reconciliation processes. Monitor printed Case Report Forms (CRFs) and Electronic Data Capture (EDC). Collection and analysis of experimental data generated in-house and externally. Qualification and monitoring of external clinical sites in accordance with study protocols and applicable regulations and standards (eg. 21 CFR Part 812, GLP, CLSI, ICH). Design of experiments (with assistance of more experienced colleagues). Develop study tools and forms (eg. Enrollment logs, Data Record Forms, Case Report Forms etc.). Contribute to the writing of study protocols and reports. Assist with site contracts and budget preparation. Train and provide technical support (trouble shooting) to external sites. Coordinate and track clinical supplies shipped and used at clinical sites. Acquisition of clinical specimens for inclusion in research or clinical studies. Maintenance of study documentation and data history files. Contribute to the writing of SOPs, DMRs, BPRs. Interact with other LMD departments and external service providers, if required (eg. Sequencing facilities, CROs). Additional Product Development & Clinical tasks, as need arises. Other duties as assigned. Education, Experience, And Qualifications Minimum B.Sc. in chemistry, biology, molecular biology or a related subject, with additional post-graduate diploma or ≥ 1 year work experience preferred but not required; OR college degree (technical subject), plus additional post-graduate diploma, plus at least 2 years work experience; OR college degree (technical subject) plus at least 3 years work experience. Previous work experience with analytical or method validation studies, preferably in GLP/GMP laboratory with an understanding of documentation requirements. List minimum education requirements and experience for the position and if there is any preferred education/experience you must identify them as preferred. What We Offer Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world. Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide. Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law. This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction. Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact View email address on click.appcast.io. Recruitment Fraud Notice Diasorin never requests payment, financial information, or personal banking details from candidates at any stage of the recruitment process. Official communications from Diasorin recruiters will only come from a verified @diasorin.com email address. If you have questions about the legitimacy of a recruitment communication, please contact View email address on click.appcast.io for verification. Unauthorized third-party recruiting agencies may not submit candidates for this position without prior written authorization from the Diasorin Human Resources Department. #J-18808-Ljbffr