Clinical Research Assistant Diasorin Biology

Clinical Research Assistant Job at Diasorin, USA | Biology Candidates, Apply Now

Clinical Research Assistant Job at Diasorin, USA. Biology, Molecular Biology, & Life Sciences Candidates, Apply Now.

If you are an analytical life sciences graduate, a molecular biology specialist, or an early-career laboratory scientist looking to translate your bench‑top method validation skills into clinical trials operations, this full‑time role at Luminex Corporation (A Dia Sorin Company) is an exceptional opportunity. Located on‑site at the molecular innovation campus in Austin, Texas, this position places you at the center of clinical study execution, site qualification, and international in vitro diagnostic (IVD) data verification.

For methodical specialists searching for a high‑prestige Clinical Research Assistant Job, this position offers hands‑on ownership across both in‑house assay design and external clinical site monitoring. It serves as an elite corporate launchpad to build an exceptional Diasorin career and stands out as a premier choice for anyone looking to secure a foundational, high‑growth Life Sciences Job in USA supporting next‑generation global immunodiagnostic submissions.

• Job Position: Clinical Research Assistant
• Location: Austin, Texas, United States
• Job Category: Research & Development

Dia Sorin is a global science‑led leader in immunodiagnostic and molecular diagnostic solutions, dedicated to combining deep scientific rigor with an entrepreneurial mindset to advance patient care worldwide. With a legacy spanning more than 50 years, the organization invests heavily in research, technology, and operational excellence to deliver an expansive specialty diagnostics portfolio across oncology, infectious disease, and metabolic conditions. Following the strategic integration of Luminex Corporation into its corporate architecture, the specialized research hub in Austin, Texas, has grown into a premier high‑throughput manufacturing and development center.

Joining this multi‑disciplinary division inserts you directly into the product development lifecycle. Your daily verification of printed and Electronic Data Capture (EDC) files and investigational device accountabilities will directly drive the regulatory dossiers cleared by global health authorities like the US FDA.

The Clinical Research Assistant functions as a vital hands‑on technical and clinical engine, taking daily operational charge of clinical data streams, specimen collection, and investigational site compliance matrices.

Your core trial execution, database auditing, and documentation duties include:

• In-House & External Study Execution: Managing day‑to‑day hands‑on work associated with analytical method validation and clinical trials for in vitro diagnostic devices.
• Investigational Site Management: Identifying, qualifying, initiating, routine monitoring, and closing out external clinical testing sites, while authoring precise monitoring reports to advance this Clinical Research Assistant Job.
• Protocol & Regulatory Alignment: Ensuring all active studies conform explicitly to study protocols, standard operating procedures (SOPs), and strict ICH/GCP, 21 CFR Part 812 (IDE), and CLSI regulations.
• Case Report Form & EDC Auditing: Monitoring printed Case Report Forms (CRFs) and Electronic Data Capture (EDC) frameworks to flag, track, and resolve discrepancies.
• Investigational Device Accountability: Managing precise instrumentation and clinical supply shipping logs, on‑site device tracking, and final inventory reconciliation processes.
• Clinical Specimen Acquisition: Coordinating the secure acquisition, de‑identification, and logging of human clinical specimens for inclusion in baseline validation protocols.
• Scientific Copy Writing: Contributing directly to the drafting of study protocols, formal testing reports, Device Master Records (DMRs), and Batch Production Records (BPRs) to support your Diasorin career.
• Site Technical Support: Conducting technical onboarding and troubleshooting training for external clinical…