Clinical Research Coordinator

Baker; Melbourne; On-site; AUD 70,000 - 110,000; Full time

Job summary

The Baker Heart and Diabetes Institute in Melbourne is seeking a Clinical Research Coordinator to lead industry-sponsored trials in diabetes, obesity and cardiovascular disease. You will partner with investigators, sponsors and monitors to ensure safe, compliant, and efficient trial conduct.

Applicants should have a bachelor's degree in health or life sciences, at least 2 years of coordinator experience, and current GCP/CPR certifications.

Qualifications

• Bachelor's degree in health, life sciences or related field.
• A minimum of 2 years' experience working as a clinical research coordinator in interventional trials involving medications or devices (not survey-only trials).
• Current certificates in GCP, CPR or Basic Life support and 'Safe Transport of Infectious Substances by Air' or CASA 92.120-compliant certification.

Responsibilities

• Lead Clinical Trial Coordination and Study Management from initiation to closeout.
• Prepare applications for research projects including HREC submissions.
• Conduct trials per protocol, manage visit schedules and activities within timelines.
• Recruit and screen potential study participants for eligibility.

Education

Bachelor's degree in health, life sciences or related field

Nursing qualification

Job description

• 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 new 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 Practice (GCP) and directions from the Human Research Ethics Committee (HREC).
  • Report Adverse Events / Serious Adverse Events within the timeframes designated for these reports.
  • Prepare for and support visits from the sponsor, clinical research organisation monitors, audits, and inspections.
• Communicate, Collaborate and Lead
  • You will serve as a primary point of contact for study participants throughout their study participation.
  • Maintain the confidentiality of participant records.
  • Liaise with Drug Company research personnel and Clinical Research Associates.
  • Meet with research investigators as required for the purpose of assessing the progress of individual studies.
  • Collaborate with other centres undertaking the same trials.
  • Contribute to the research and professional activities of the department.
  • Attend team meetings and all relevant seminars and staff meetings.
  • Maintain professional qualifications required for clinical trial work, e.g. GCP and IATA certification, venepuncture training, cardiopulmonary resuscitation (CPR) training.
  • Ensure the scientific integrity of research work and established data emanating from your research done at or performed at this Institute.
  • Mentor/ onboard other clinical trial coordinators as needed.
• Like all roles at the Baker Institute, this position may occasionally involve duties beyond those listed here, as reasonably directed by your manager.

Education level and experience

• Bachelor's degree in health, life sciences or related field, or nursing qualification.
• A minimum of 2 years' experience working as a clinical research coordinator in interventional trials involving medications or devices (not survey-only trials).
• Current certificates in
  • GCP
  • CPR or Basic Life support
  • 'Safe Transport of Infectious Substances by Air' Course or other certificate meeting the requirements of CASA 92.120 (Infectious Substances, Biological Substances Category B and associated storage and transport media including Dry Ice).
• Previous venepuncture, ECG and sample processing 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.

Communication/interpersonal skills

• A high level of interpersonal skills, which enables the appointee to liaise effectively with a wide range of people at a variety of levels internal and external to this Institute.
• Excellent oral and written communication skills.
• Demonstrated ability to participate positively in a team.
• Demonstrated ability to maintain confidentiality of participant records.

Abilities

• Has self-motivation, integrity and reliability.
• Able to work independently and exercise initiative to resolve problems.
• Has strong organisational skills, attention to detail, and ability to prioritise and multi-task to meet multiple deadlines.
• Has a caring attitude towards study participants.
• Able to be part of a team and work professionally with different people.
• Experience with glucose meters including continuous glucose monitoring (desirable).
• Meet screening, recruitment and retention targets for each clinical trial.
• Accurate, timely recording of data.

Our values

Everything we do at the Baker Institute is guided by five values — and we look for people who bring these to life in their work, not just in their words.

Human-centred

We put people at the centre of everything we do. Whether it is a patient, a partner, or a peer, we care deeply about real-world outcomes. We do not stop at publishing — we conduct research to improve lives.

Empathy

We believe good health is a human right. We listen, include and advocate for those who are often unheard. Compassion shapes how we communicate, collaborate, and create change.

Accountability

We hold ourselves to the highest standards. Whether in research, leadership or relationships, we take ownership of our work and our impact. We do what we say — and we say why it matters.

Respect

We recognise the dignity of every individual — from patients and study participants to colleagues and collaborators. We embrace diversity and foster an environment where all contributions are respected.

Transformative

Our curiosity fuels innovation and will redefine what is possible. Being transformative means pushing boundaries, challenging the status quo and turning pioneering research into real-world breakthroughs.

Working at the Baker Institute

Travel to meetings related to clinical trials is required. These may be local, elsewhere in Australia, or overseas, although this is infrequent. Travel to Baker Heart and Diabetes Institute clinics for clinical trial recruitment will be needed. The clinics are located in Melbourne and in Footscray.

Equal Opportunity Employer

The Baker Institute is an Equal Opportunity Employer, and we encourage interest from Aboriginal and Torres Strait Islanders and members of the LGBTIQ+ community for roles within the Institute. We value diversity, inclusivity, gender equity and we promote family-friendly practices. We are a proud recipient of an inaugural Athena SWAN Bronze Award from Science in Australia Gender Equity (SAGE).

We offer a range of benefits designed to help our people feel valued, stay well and do your best work, whatever that looks like for you.

Should you have any general questions or need more information, please don't hesitate to contact our friendly People Experience team on [e-mail] .

Life at the Baker Institute

From salary packaging and flexible working to mentoring and career development — we invest in our people.

To be eligible to apply for this position, you must have appropriate Australian full working rights.

Offers of employment are subject to satisfactory background checks prior to commencement in the position.

The Baker Institute is an Equal Opportunity Employer. We are committed to fostering a diverse, gender equitable workforce where everyone is welcome, and all applications are evaluated on merit and potential. We encourage applications from Aboriginal and Torres Strait Islander Peoples, people living with disabilities, culturally diverse people, those at any stage in life, and people within LGBTQ+ communities, including trans and gender diverse. We promote family-friendly practices. We’re a proud recipient of an inaugural Athena SWAN Bronze Award from Science in Australia Gender Equity (SAGE).