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About the Role

The Clinical Research Associate will be responsible for conducting day-to-day work associated with analytical and clinical studies for in vitro diagnostic devices. This includes planning and execution of in-house clinical studies, as well as training and monitoring of external clinical sites.

Responsibilities

• Conduct 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 and review and finalize them.
• 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).
• Collect and analyze experimental data generated in-house and externally.
• Qualify and monitor external clinical sites in accordance with study protocols and applicable regulations and standards (e.g., 21 CFR Part 812, GLP, CLSI, ICH).
• Design experiments (with assistance of more experienced colleagues).
• Develop study tools and forms (e.g., Enrolment 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.
• Acquire clinical specimens for inclusion in research or clinical studies.
• Maintain 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 (e.g., Sequencing facilities, CROs).
• Perform additional Product Development & Clinical tasks, as needed.
• Perform other duties as assigned.

Requirements

• 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.
• College degree (technical subject), plus additional post-graduate diploma, plus at least 2 years work experience.
• 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.
• Individuals hired will be required to verify identity and eligibility to work.
• Individuals hired may be subject to a background check and drug screening where permitted by law.

Skills

• Analytical studies
• Clinical studies
• In vitro diagnostic devices
• Good Clinical Practice (GCP)
• Good Laboratory Practice (GLP)
• Data analysis
• Trouble shooting

Location

• Global

Work Type

• Full-time

Experience Level

• Minimum 1 year work experience preferred
• Minimum 2 years work experience
• Minimum 3 years work experience

Education Level

• B.Sc. in chemistry, biology, molecular biology or a related subject
• Post-graduate diploma
• College degree (technical subject)

Benefits

• Competitive salary and benefits package

About the Company

• Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide.
• For more than 50 years, Diasorin has combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.
• 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.
• 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.

Equal Opportunity

• 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.
• Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process.