Clinical Research Associate (CRA) / Australia

Clinical Research Associate

We are seeking a Clinical Research Associate (CRA) for our leading Sydney located Orthopaedic specialists to assist with execution of multiple studies that are correctly designed, initiated, coordinated and completed to provide the highest level of scientific evidence and most effective outcomes for our patients.

The professiona practice is fundamentally informed by evidence-based medicine, and research is therefore an important component of the portfolio of every staff member in the organisation. 

Research is conducted under the supervision of the Director of Research and Fellowship Training and the Clinical Research Manager, and is focused on enquiries that will improve outcomes for our patients and contribute to orthopaedic science internationally.

The team is currently involved in investigation of topics such as kinematic knee alignment, soft tissue balancing techniques, robot-assisted arthroplasty and various sports medicine questions.

The role

• Coordination of clinical research studies
• Management of logistics, timelines, monitoring,reporting and documentation for each project
• Communication with ethics committees and study sites
• Creation of ethics applications and associated governance documents
• Set-up of study sites, followed by training & collaboration with on-site personnel
• Participation in project team meetings to review progress of ongoing trials
• Meticulous data acquisition and data verification from source documents
• Specific attention to upkeep of accurate, accessible records in the research database
• GCP-compliant archival of study documentation and correspondence
• Maintenance of clinical trial files in an inspection-ready state
• Proactive identification and resolution of study-related issues

You

• Positive 'can do attitude'
• Minimum of a bachelor’s degree in the biomedical sciences
• 2+ years’ experience in a clinical research setting, with medical or CRO research preferred
• Proven ability to manage multiple projects in an organised and logical fashion
• Experience working with Human Research Ethics Committees, including creation, submission and successful approval of applications (both low-risk and full-committee pathways)
• Thorough knowledge of Good Clinical Practice (GCP) and Australian TGA regulations for clinical trials and track record of applying them
• Full, unrestricted working rights in Australia
• Ability to work on-site at Kogarah location