Clinical Research Assistant

Diasorin•Austin, TX

11d

About The Position

The 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.

Requirements

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

Nice To Haves

additional post-graduate diploma or ≥ 1 year work experience preferred but not required
additional post-graduate diploma, plus at least 2 years work experience
at least 3 years work experience

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.