Clinical Research Assistant

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.
• 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 (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.

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.