New

Clinical Operations Coordinator

DiaSorin
United States, Texas, Austin
Jan 10, 2025
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 This position plays an integral role in the development, and maintenance of Clinical laboratory procedures, equipment and activities in accordance with Clinical Affairs timeline requirements as well as implementation and maintenance of CTMS system, materials supply and logistics, document control, communicating activities and timelines to cross-functional core teams, creation of organizational streamlining strategiesadministrative role related to CTMS. Working closely with Clinical Trial Managers/Coordinators, Clinical Lab team, Data Management team, and Global Logistics to ensure project tasks are managed to completion. Working knowledge of databases and programs and perform administrative tasks to support the team members with clinical trial execution as needed. 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. What you will do Schedule and/or perform instrument and equipment qualification and maintenance and repair. Troubleshoot equipment activities or coordinate vendor services as needed Document laboratory activities to include calibration, verification, qualification, maintenance of equipment. Maintain inventory management system ensuring traceability of biological materials Purchase common laboratory materials and reagent supplies. Ship and receive laboratory supplies, instruments and reagents. Stock and organize laboratories for optimum functionality Assist in design of laboratory work flow and space design to include relocation of laboratory equipment and supplies. Install or relocate laboratory equipment for new and ongoing projects in conjunction with other departments and user groups as needed Interface across the organization and work closely with other functional groups, such as, Clinical Affairs, Design Transfer, Manufacturing, and Quality Control regarding priorities and timetables for deliverables Comply with the company's Quality Management System policies and procedures; and, monitor laboratories for compliance with safety requirements Conduct laboratory experiments as necessary. This involves working in Biosafety Level II laboratory with biological samples and nucleic acid extractions Work with Global Logistics to ship infectious materials and ensure all transport/import permit requirements for infectious material are met Supply shipments/tracking Responsible for set up, maintenance and metrics reporting from CTMS for clinical studies Establishes and maintains trial master files in compliance with SOPs, ICH and GCPs Coordinate clinical operations projects as needed Other duties as assigned Education Qualifications High School Diploma plus 2+ years inbiochemistry, biology, molecular biology, or a related scientificfield experience- Required OR Associate's Degree inCommunity College 2-year diploma (technical) in biochemistry, biology, molecular biology, or a related scientific field- Preferred OR Bachelor's Degree -Bachelor degree in biological/chemical or related scientific disciplines with no relevant experience/training- Preferred Experience Qualifications 1+ Years Expertise in a variety of molecular and biochemical laboratory procedures required 1+ Years Working knowledge or experience with ISO 13485:2016 standards and FDA regulations preferred 1+ Years Prior medical device industry experience preferred Training and Skills Excellent oral and written communication skills (High proficiency) Ability to handle the pressure of meeting tight deadlines (High proficiency) Excellent interpersonal skills with proven ability to work both in a team-oriented environment and independently (High proficiency) Knowledge of Design Control requirements as defined by the FDA Quality System guidelines (Low proficiency) Proficient in hands-on laboratory work (Medium proficiency) Mathematics and statistics aptitude (Medium proficiency) Data analysis and technical writing aptitude (Medium proficiency) Proficient in Microsoft Word, Excel, and PowerPoint programs (Medium proficiency) Highly organized with proven time management and prioritization skills (Medium proficiency) Ability to work independently and with minimal supervision (Medium proficiency) Travel Requirements 90% Must work onsite at Luminex office 20% Travel may be required 10% International 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. 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 hrtalent@diasorin.com 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.