Clinical research associate Job at DiaSorin, Austin, TX

  • DiaSorin
  • Austin, TX

Job Description

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.

Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

Job Scope

Conducting day-to-day work associated with analytical and clinical studies conducted by Luminex, A DiaSorin Company for inclusion in regulatory submissions for in vitro diagnostic devices. Planning and execution of in-house clinical studies as well as training and monitoring of external clinical sites.

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.
  • Monitor printed Case Report Forms (CRFs) and Electronic Data Capture (EDC)
  • Collection and analysis of experimental data generated in-house and externally.
  • Qualification and monitoring of external clinical sites in accordance with study protocols and applicable regulations and standards (eg. 21 CFR Part 812, GLP, CLSI, ICH)
  • Design of experiments (with assistance of more experienced colleagues)
  • Develop study tools and forms (eg. Enrolment logs, Data Record Forms, Case Report Forms etc.)
  • Contribute to the writing of study protocols and reports.
  • Assist with site contracts and budge preparation.
  • Train and provide technical support (trouble shooting) to external sites.
  • Coordinate and track clinical supplies shipped and used at clinical sites.
  • Acquisition of clinical specimens for inclusion in research or clinical studies
  • Maintenance of 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
  • List minimum education requirements and experience for the position and if there is any preferred education/experience you must identify them as preferred.

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 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.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at or 1-800-328-1482 to request an accommodation.

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.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.

Job Tags

Full time, Work experience placement, Local area, Worldwide,

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