Clinical Research Associate

About the role

The Clinical Research Associate will be responsible for conducting day-to-day work associated with analytical and clinical studies conducted by Luminex, a subsidiary of DiaSorin. This includes planning and executing in-house clinical studies, training and monitoring external clinical sites, and ensuring studies comply with regulatory guidelines.

Responsibilities

• 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;
• Maintain study documentation and data history files;
• Contribute to the writing of SOPs, DMRs, BPRs;
• Coordinate and track clinical supplies shipped and used at clinical sites;
• Maintain 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 of 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;
• Aid in site contracts and budget preparation;
• Train and provide technical support (troubleshooting) to external sites;
• Acquire clinical specimens for inclusion in research or clinical studies;
• Contribute to the writing of SOPs, DMRs, BPRs;
• Interact with other LMD departments and external service providers, if required (e.g., sequencing facilities, CROs).

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;
• 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;
• Ability to work independently and as part of a team;
• Strong organizational and time management skills;
• Excellent communication and interpersonal skills;
• Proficiency in Microsoft Office applications;
• Knowledge of Good Laboratory Practices (GLP) and Good Clinical Practices (GCP).

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;
• Ability to work independently and as part of a team;
• Strong organizational and time management skills;
• Excellent communication and interpersonal skills;
• Proficiency in Microsoft Office applications;
• Knowledge of Good Laboratory Practices (GLP) and Good Clinical Practices (GCP).

Benefits

Diasorin offers a competitive salary and benefits package, including health insurance, retirement plans, and opportunities for professional development. We also provide a supportive and inclusive work environment where employees can contribute ideas, take ownership, and grow their careers.

Pay

Competitive compensation package based on experience and qualifications.

Schedule

Full-time position with flexible hours to accommodate clinical study needs.

Skills

• Strong analytical and problem-solving skills;
• Excellent communication and interpersonal skills;
• Proficiency in Microsoft Office applications;
• Knowledge of Good Laboratory Practices (GLP) and Good Clinical Practices (GCP).

Benefits

• Health insurance;
• Retirement plans;
• Professional development opportunities;
• Flexible work schedule;
• Opportunities to contribute to impactful projects.

Company Information

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. Founded in 1968, Diasorin operates with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions. Our mission is to build what matters, innovate with agility at a global scale, and grow in a people-centered culture.

Equal Opportunity Employer

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.