About the 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.

Key responsibilities

- 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, managing complex study visit schedules and protocol-related activities within study timelines
- Lead participant recruitment and retention efforts by identifying and recruiting potential study participants and screening them for suitability according to eligibility criteria
- Participate in required training for clinical trials involving third party vendors (e.g. electronic data capture, continuous glucose monitoring, ECG transmission), including virtual meetings and in-person training days
- Manage participant appointments, book clinical research rooms for study visits, and book procedures as required by protocol




- Organise prescriptions and pickup of investigational product from the Alfred Clinical Trial Pharmacy
- Perform venepuncture and handle, process, transport and store blood and urine specimens in accordance with safety procedures and protocol requirements
- Maintain accurate, complete, and timely study documentation including source records, informed consent forms, EDC updates, and case report forms
- Report Adverse Events and Serious Adverse Events within designated timeframes
- Serve as primary point of contact for study participants throughout their study participation
- Maintain confidentiality of participant records
- Liaise with Drug Company research personnel and Clinical Research Associates
- Collaborate with other centres undertaking the same trials
- Mentor and onboard other clinical trial coordinators as needed

About you

- Bachelor's degree in a health, life sciences or related field, or nursing qualification
- Minimum 2 years' experience working as a clinical research coordinator in interventional trials involving medications or devices
- Current certificate in GCP
- Current certificate in CPR or Basic Life support
- Current certificate in 'Safe Transport of Infectious Substances by Air' Course or other certificate meeting the requirements of CASA 92.120
- Previous venepuncture, ECG and sample processing experience




- Previous participant recruitment experience
- Previous experience in preparation of HREC submissions
- Proficiency in use of computer software applications used for research systems
- Proficiency in assessing and implementing research protocols and operational workflows
- Understands the legal aspects of running a clinical trial
- High level of interpersonal skills to liaise effectively with a wide range of people at various levels
- Excellent oral and written communication skills
- Demonstrated ability to participate positively in a team
- Self-motivation, integrity and reliability
- Able to work independently and exercise initiative to resolve problems
- Strong organisational skills, attention to detail, and ability to prioritise and multi-task
- Caring attitude towards study participants
- Experience with glucose meters including continuous glucose monitoring (desirable)

About us

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. 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.

Perks

We offer a range of benefits designed to help our people feel valued, stay well and do your best work. For more information, visit baker.edu.au/career/staff-benefits.

📌 Clinical Research Coordinator (Melbourne)
🏢 Baker Heart And Diabetes Institute
📍 Melbourne