Job ScopeThe Clinicial Research Associate will be responsible for 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 6gt;= 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 offerReceive 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.
