21 Oct
|
BAKER
|
Melbourne
- Department: Clinical Diabetes and Epidemiology
- Manager: Prof Jonathan Shaw and Dr Anne Reutens
ABOUT THE BAKER INSTITUTE
Since 1926, the Baker Heart and Diabetes Institute has been at the centre of some of the world's most significant breakthroughs in heart and diabetes research. As Australia's only independent medical research institute dedicated solely to these conditions, we've spent nearly a century turning discovery science into real-world change. Heart disease remains a leading cause of death in Australia. Diabetes is the fastest-growing chronic condition in the country. The problem still exists — and that's exactly what drives us. Our scientists, clinicians, public health experts, diabetes educators, and dietitians work together every day with one shared purpose: to help people live healthier for longer. If you want to be part of that work, read on.
Position Overview
The Baker Institute is the nation's first multi-disciplinary organisation tackling the deadly trio of obesity, diabetes and cardiovascular disease through research, education and patient care. We rely on a range of skilled professionals, doctors, researchers and trial coordinators, to achieve our mission. As our current Clinical Research Coordinator, you will play a vital role in conducting clinical trials that will advance the care and treatment of participants who have diabetes, overweight/obesity or cardiovascular disease.
About this role
As Clinical Research Coordinator, you will play a critical role in conducting pharmaceutical industry-sponsored clinical studies, involving investigational products. You will work closely with the principal investigator, patients, doctors, study sponsors, monitors, regulatory teams and other healthcare professionals.
You will act as liaison between these groups. You will provide excellent support for the trial participants and ensure they have a wonderful trial experience. By conducting these research studies safely, ethically and in compliance with regulatory requirements, you will be assuring that these drugs are thoroughly assessed for potential future clinical use.
Our team
Our clinical research team is embedded within the Clinical Diabetes and Epidemiology Department. You will be working with two endocrinologists, one who is the head of department and another endocrinologist who is the principal investigator for the trials.
Key responsibilities
- Lead Clinical Trial Coordination and Study Management:
- Coordinate industry-sponsored clinical trials from study site initiation through to closeout visits.
- Prepare applications for research projects as appropriate, including Human Research Ethics Committee submissions.
- Conduct clinical trials according to trial protocols, which means you can manage complex study visit schedules and protocol-related activities within study timelines.
- Lead the participant recruitment and retention efforts, which means you identify and recruit potential study participants by medical record review or advertising, and screen them for suitability for study trials as per eligibility criteria.
- Participate in the required training for the clinical trials involving third party vendors (e.g. for electronic data capture (EDC), continuous glucose monitoring, ECG transmission). This may require attendance at virtual meetings as well as attendance in person at specific training days held at various locations (including overseas) designated by study sponsors.
- Manage participant appointments, book clinical research rooms for study visits, book procedures done by collaborating units, as required by the protocol.
- Organise prescriptions and pickup of investigational product from the Alfred Clinical Trial Pharmacy.
- Carry out all relevant study-related tasks, ensuring adherence to protocol.
- Perform venepuncture, and deal with handling, processing, transport and storage of blood and urine specimens. This includes maintaining awareness of appropriate blood handling procedures in relation to safety and laboratory techniques, as well as preparing shipments in accordance with protocol requirements and applicable International Air Transport Association (IATA) regulations.
- Maintain accurate, complete, and timely study documentation including source records, informed consent forms, EDC updates, and case report forms.
- Ensure appropriate investigator review and documentation in a timely manner.
- Resolve data queries in a timely manner.
- Order consumables for trials and arrange other personnel/resources for trials as required. Maintain inventory and organisation of study equipment and supplies onsite.
- Ensure participant safety during involvement in clinical trials by adhering to federal, state, institutional regulatory requirements, the Institute's Standard Operating Procedures (SOPs), rules of Good Clinical Practic
📌 Clinical Research Coordinator (Melbourne)
🏢 BAKER
📍 Melbourne