Biochemist

Employer - RDC Global Pty Ltd, trading as RDC Clinical

Position : Full-time, 38 hours per week

Location : Level 3, 252 Saint Pauls Terrace, Fortitude Valley QLD 4006

Salary : $80k-$82k plus superannuation

About the role:

RDC Clinical is a Brisbane contract research organisation that runs human clinical trials of complementary medicines, nutraceuticals and pharmaceutical products.

The Biochemist performs the biochemical and immunological analyses that underpin these trials. The role combines laboratory analysis with clinical trial work: conducting study visits, timing and processing samples for bioavailability and pharmacokinetic studies, and keeping specimens and data compliant with ICH Good Clinical Practice and sponsor requirements.

Key duties

Conducting biochemical analyses relating to vitamins, supplements, and biologically relevant compounds through the application of analytical and biochemical laboratory techniques.

Performing enzyme-linked immunosorbent assays (ELISA), including calibration standard preparation, assay optimisation, quality control implementation, and interpretation of analytical outputs to ensure scientific accuracy, sensitivity, and reproducibility of results.

Processing, handling, and managing biological specimens including plasma, serum, and peripheral blood mononuclear cells (PBMCs) under controlled laboratory conditions to maintain specimen integrity for downstream biochemical and molecular analysis.

Overseeing laboratory operational functions including sample traceability systems, inventory management, specimen storage, and sample identification procedures in accordance with regulatory and laboratory standards.

Coordinating the shipment and transfer of biological samples to external laboratories and sponsoring organisations while ensuring compliance with transport, storage, and documentation requirements.

Contributing to validation, troubleshooting, and quality assurance activities to maintain the robustness, consistency, and reliability of laboratory methodologies and analytical procedures.

Applying biochemical principles relating to nutrient metabolism, molecular interactions, metabolic pathways, and physiological responses to support laboratory investigations and scientific research activities.

Providing guidance and support to laboratory personnel to ensure adherence to established protocols, quality standards, and best laboratory practices within a multidisciplinary laboratory environment.

Conducting participant study visits in accordance with the approved protocol, ICH Good Clinical Practice (GCP) and RDC standard operating procedures.

Planning and performing timed sample collection and processing for bioavailability and pharmacokinetic (PK) studies within protocol-specified windows.

Applying knowledge of complementary medicines and nutraceuticals, including ingredient absorption and bioavailability, to sample handling and interpretation of results.

Recording study and sample data in the Clinical Trial Management System (RealTime-CTMS) and source documents to monitoring and audit standard.

Supporting sponsor-led external monitoring of studies, including preparing laboratory and sample records for source data verification and resolving monitor queries within agreed timeframes.

Assisting with the preparation, scientific review, interpretation, and analysis of research manuscripts associated with biochemical and metabolic investigations.

Selection criteria

Essential

Bachelor degree or higher in biochemistry or a closely related life science.

Experience with ELISA and with processing plasma, serum and PBMC (minimum 12 months)

Experience in human clinical trials, including timed sampling for bioavailability or PK studies (minimum 18 months)

Knowledge of complementary medicines or nutraceuticals, including ingredient absorption.

Current ICH-GCP training.

Experience with externally monitored clinical trials, including source data verification and resolving monitor queries (minimum 18 months)

Experience with RealTime-CTMS (minimum 18 months)

Authorship or co-authorship of peer-reviewed scientific publications, preferably in nutrient metabolism, bioavailability or human physiology.