Australia is the ideal location for clinical trials due to our world class health system, R&D tax incentives, efficient regulatory pathway, ethnically diverse population, quality research infrastructure and skilled workforce including Dedicated Clinical Research Coordinators.
What makes a Dedicated Clinical Research Coordinator the ideal solution for Sponsors seeking to conduct clinical trials Australia wide?
Commitment to safety and wellbeing of participants above all things.
Experienced Nurse (and back up Nurse) dedicated to coordinating the study at site, available Australia wide.
ICHGCP Certified and AHPRA Registered.
Works remotely when not needed at site and charges only for hours worked.
Prioritises the trial at site and study timelines.
Works strictly within safety, regulatory and ethical guidelines.
Ensures high priority is given to meeting patient recruitment goals within timelines.
Flexible approach to achieving targeted patient recruitment.
Study visits are planned and conducted within visit window, equipment maintained, and accountability logs completed.
Participants well informed and supported throughout the study.
Careful consideration to undertaking and documentation of consent process.
Adverse Event and Serious Adverse Event reporting.
Essential key documentation including CV’s, ICHGCP certification, insurances, and the Site Master File
Source document completion using ALCOAC principles.
Version control of protocol, PICF, source documents and amendments.
Always audit ready.
Regular Sponsor communication updates
Strategies to overcome site challenges.