Clinical Study Coordinator

3 weeks ago

Toronto, Canada DiaSorin Full time

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.
Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."
Why Join Diasorin?
**Impactful Work**: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.
**Global Reach & Innovation**: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
**Diverse and Inclusive Culture**: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.
**Join Our Team**: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.
Job Posting
Our Mission
We envision a Luminex solution in every lab around the world seeking to obtain timely and confident answers.
Our Vision
We aim to lead with transformative solutions that uniquely accelerate reliable answers while reducing the overall cost of advancing health.
A Brief Overview
The Clinical Study Coordinator will be responsible for
This position 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 logístical 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.
What you will do
Day-to-day “hands on” work associated with in-house clinical studies
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.)
Coordinate execution of site contracts and site budget preparation
Coordinate and track clinical supplies shipped and used at clinical sites
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 Qualifications
Experience Qualifications
1+ Years Previous work experience with clinical trials, analytical or method validation studies preferred. preferred
Training and Skills
Excellent communication, organizational and time management skills
Proficiency with Microsoft Office software
Travel Requirements
10% domestic travel
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, or protected veteran status, and will not be discriminated against on the basis of disability.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.
The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.
The salary range is $60,000 to $70,000 dependent on education and work experience.
AI tools are not utilized to screen applicants.
Diasorin reserves the right to modify or amend this job posting as needed to

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