Clinical Studies Coordinator

DiaSorin; Stillwater (MN); On-site; USD 73,000 - 89,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Annual incentive program

Wellbeing support

Job summary

DiaSorin is seeking a Clinical Studies Coordinator to support new assay/product development and clinical studies by coordinating data and regulatory documentation. The role will work with internal teams and CROs, ensuring GCP compliance and proper archival of study materials.

Onsite in Stillwater, MN with 10% travel. Responsibilities include building regulatory binders, maintaining data, managing study databases, and coordinating monitoring visits.

Qualifications

• Bachelor's Degree with 1–2 years related experience (or equivalent).
• Competent in MS Excel, Access and Word; familiarity with Google Suite.
• Ability to read and interpret documents such as safety rules and manuals; write routine reports.
• Ability to perform basic arithmetic and units conversion for money and measurements.
• Ability to follow written, verbal, or diagrammed instructions with common sense.
• Ability to handle problems with several concrete variables in standardized situations.

Responsibilities

• Build regulatory binders for clinical sites.
• Maintain clinical sample and device accountability; shipments and logs.
• Maintain study databases; identify data discrepancies and query sites as appropriate.
• Coordinate regulatory binder, monitoring visits (remote and onsite) and data queries with CRO and sites.
• Ensure GCP study conduct throughout the study.
• Coordinate and file study/site document archives.
• Train and work with internal and external team members for clinical activities.
• Perform tasks in accordance with EHS regulations and company policies.
• Performs other duties as assigned.

Education

Bachelor's Degree and 1–2 years related experience

Tools

MS Excel

MS Access

MS Word

Google Suite

Job description

Clinical Studies Coordinator

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

Provide support to new assay/product development and clinical studies by coordinating and compiling the clinical data, perform administrative tasks as part of clinical project teams to support the completion of clinical trial/regulatory documentation and processes. Support applicable regulations including ISO, Local, State, and/or Federal requirements.

This role is onsite at our Stillwater, MN location.

Job Responsible and Duties

• Build and maintain clinical regulatory binders for clinical sites.
• Maintain clinical sample and device accountability; including shipments and logs.
• Maintain clinical study databases for internal and external clinical sites. Identify data discrepancies and query sites as appropriate.
• Coordinate regulatory binder, monitoring visits (remote and onsite) and data queries with CRO and clinical sites, as appropriate.
• Ensure GCP study conduct throughout the study.
• Coordinate and file study and site document archives.
• Train and work with internal and external team members, as requested for the completion of clinical activities
• Perform assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies.
• Performs other duties as assigned

Education, Experience and Qualifications

• Bachelor's Degree and one to two years related experience and/or training; or equivalent combination of education and experience. required
• Competent in MS Excel, Access and Word. Familiarity with Google Suite
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence
• Ability to add and subtract two digit numbers and to multiply and divide with 10's and 100's. Ability to perform these operations using units of American money and weight measurements, volume, and distance
• Ability to apply common sense understanding to carry out instructions furnished in written, verbal, or diagram form
• Ability to deal with problems involving several concrete variables in standardized situations

Standard Physical Demands

• Specific vision abilities required by this job include close vision. - Constantly

Travel Requirements

• 10% travel possible

What we offer

The posting range for this position is $73,000 - $89,000 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, 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.

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 [e-mail].