Clinical Study Coordinator

DiaSorin; Austin (TX); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Wellbeing support

Job summary

DiaSorin is seeking a Clinical Study Coordinator in Austin, Texas, to support analytical and clinical studies involving Luminex in vitro diagnostic devices. The role includes planning in-house studies, monitoring external sites, and ensuring compliance with global regulations (e.g., 21 CFR Part 812, CLSI, ICH).

This position involves budget tracking, data collection, and collaboration with various internal and external stakeholders.

Qualifications

• Bachelor's Degree in a technical subject; 3+ years in clinical studies.
• Experience with site contracts, budgets, and regulatory standards (21 CFR Part 812, ICH).
• Excellent communication, organizational, and time-management skills.
• Proficiency in Microsoft Office.

Responsibilities

• Manage day-to-day in-house clinical studies.
• Coordinate site contracts and budgets.
• Process invoices and monitor study budgets.
• Track clinical supplies at sites.
• Collect and analyze data from studies.
• Support site qualification and monitoring per protocols.
• Develop study tools and forms.
• Collaborate with sample bank for specimens.
• Maintain study documentation and data history.
• Keep SOPs and protocols up to date.
• Interface with internal departments and CROs as needed.
• Additional product development and clinical tasks as needed.
• Other duties as assigned.

Skills

Clinical coordination

Regulatory knowledge

Communication

Microsoft Office

Budgeting

Education

Bachelor's in chemistry/biology

Master's preferred

Post-graduate diploma or 1+ year experience

Job description

Clinical Study Coordinator

The Clinical Study Coordinator plays an integral role in supporting the conduct of analytical and clinical studies involving Luminex in vitro diagnostic devices, planning and execution of in-house clinical studies, and qualification and monitoring of external clinical sites in accordance with Clinical Affairs timeline requirements. The role also involves activities related to the logistical requirements for the execution of clinical studies in accordance with applicable global regulations and standards (e.g. 21 CFR Part 812, CLSI, ICH) that demonstrate the performance and utility of in vitro diagnostic products.

Duties and Responsibilities

• Day‑to‑day “hands on” work associated with in‑house clinical studies
• Coordinate execution of site contracts and site budget preparation
• Process invoices for payment and track project‑specific budgets and spending
• Coordinate and track clinical supplies shipped and used at clinical sites
• Collection and analysis of experimental data generated in‑house and externally
• Assist with site qualification processes and support monitoring of external clinical sites in accordance with study protocols and applicable regulations and standards (eg. 21 CFR Part 812, GLP, CLSI, ICH)
• Develop study tools and forms (eg. Enrollment logs, Data Record Forms, Case Report Forms etc.)
• Collaborates with sample bank to acquire and dispense clinical specimens for use at external clinical sites
• Maintenance of study documentation and data history files
• Maintain working knowledge of current protocols and internal SOPs.
• Interact with other internal Luminex 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

• Bachelor's Degree technical subject plus at least 3 years' work experience (required)
• Bachelor's Degree in chemistry, biology, molecular biology or a related subject, with additional post‑graduate diploma or ≥ 1 year work experience preferred but not required
• Master's Degree technical subject plus at least 2 years' work experience (preferred)
• 1+ Years Previous work experience with clinical trials, analytical or method validation studies (preferred)
• Excellent communication, organizational and time management skills
• Proficiency with Microsoft Office software

What we offer

Diasorin offers a competitive rewards package focused on your overall well‑being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.

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 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.

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.