Clinical Study Coordinator
About The Position
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.
Requirements
- Bachelor's Degree technical subject plus at least 3 years' work experience.
- Excellent communication, organizational and time management skills
- Proficiency with Microsoft Office software
Nice To Haves
- 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.
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
Benefits
- competitive rewards package focused on your overall well-being
- comprehensive plan of health benefits
- retirement and financial wellbeing
- time off programs
- wellbeing support and perks
- annual incentive program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
