The Haematology Clinical Trials Unit (HCTU) provides coordinated support for the delivery of clinical research at Canberra Hospital and plays an important role in improving care for patients with malignant and non-malignant haematological conditions. Through participation in national and international clinical trials, the Unit supports patients to access innovative therapies, emerging treatment pathways and research-informed models of care, including where standard treatment options may be limited. The HCTU manages a diverse portfolio of pharmaceutical-sponsored trials, registries, investigator-led research and collaborative studies at different stages of the clinical trial lifecycle.

The Lead Clinical Trials Coordinator is a senior clinical and operational leadership role within the HCTU. Working under the limited direction of the Clinical Trials Manager and in close collaboration with Principal Investigators, Clinical Haematologists and multidisciplinary teams, the position provides day-to-day supervision and operational leadership to the HCTU clinical trials coordination team. This includes supporting staff performance, professional development and daily workforce coordination, while escalating formal workforce and performance matters to the Clinical Trials Manager.

The position acts as the primary operational point of contact and escalation for HCTU staff, investigators, sponsors, monitors and other stakeholders. The role oversees the safe, effective and compliant operational delivery of the HCTU clinical trials portfolio, ensuring that trial activities are coordinated in accordance with approved protocols, Good Clinical Practice and applicable ethics, governance and organisational requirements.

The role applies advanced nursing knowledge, clinical judgement and research coordination expertise in an environment where patient-centred care is supported by accurate documentation, data integrity, regulatory compliance and effective stakeholder coordination. The position provides senior guidance and troubleshooting support to the coordination team and promotes consistent, high-quality clinical trial practices across the Unit.

The Lead Clinical Trials Coordinator also leads the operational assessment and monitoring of trial feasibility, working with Principal Investigators and the Clinical Trials Manager to consider unit capacity, workforce availability, operational requirements and portfolio sustainability. The position contributes to continuous improvement, workforce capability and the broader development of clinical trials capacity across Canberra Health Services.

This role is well suited to an experienced registered nurse who can combine advanced clinical judgement with team leadership, complex operational coordination and a strong commitment to safe, ethical and high-quality clinical research.

Specific responsibilities include, but are not limited to, the following.

Under the limited direction of the Clinical Trials Manager, and working closely with Principal Investigators, Clinical Haematologists, and multidisciplinary teams, the Lead Clinical Trials Coordinator provides senior clinical coordination and day-to-day leadership of the Haematology Clinical Trials Unit team. The role applies advanced nursing knowledge, clinical judgement, and supervisory expertise to ensure the delivery of safe, ethical, high-quality, and patient-centred clinical trial services.

Key responsibilities include, but are not limited to, the following:

1. Provide day-to-day supervision and operational leadership to the HCTU clinical trials coordination team, supporting staff performance, professional development and daily workforce coordination, and escalating formal workforce or performance matters to the Clinical Trials Manager.
2. Act as the primary operational point of contact and escalation for the HCTU clinical trials portfolio, overseeing the coordination and operational delivery of multicentre Phase I, II and III clinical trials, registries and local research projects, and ensuring activities are delivered in accordance with approved protocols, Good Clinical Practice and governance requirements.
3. Support the Clinical Trials Manager with HCTU workforce functions, including contributing to recruitment, onboarding, leave coordination, staff development and performance processes, and maintaining accurate workforce records and reporting as required.
4. Provide training, guidance, and troubleshooting support to the HCTU coordination team across all aspects of trial management, including ethics and governance submissions, associated budgets and regulatory documentation, and study start-up, amendment, and maintenance processes, working in collaboration with investigators, sponsors, and internal stakeholders.
5. Serve as a senior point of contact for patients, sponsors, monitors, and multidisciplinary stakeholders within the HCTU, facilitating effective communication, escalation of issues, and consistent delivery of patient-centred trial coordination.
6. Lead the assessment of trial feasibility for proposed and ongoing studies, evaluating unit capacity, workforce availability, and operational requirements in collaboration with Principal Investigators and the Clinical Trials Manager.
7. Ensure the maintenance of accurate and timely trial documentation across the HCTU portfolio, including coordinating requirements for and validating trial-related Digital Health Record content and workflows, electronic case report forms and relevant databases, with accountability for data integrity and compliance with Good Clinical Practice and organisational standards.
8. Contribute to the development and continuous improvement of unit processes, standard operating procedures, and operational practices, working with the Clinical Trials Manager to support quality, efficiency, and the growth of HCTU capacity.
9. Participate in and support professional development activities relevant to clinical trials coordination and team leadership, including attendance at investigator meetings and engagement with national and international research activity, and foster a culture of learning and development within the HCTU team.
10. Undertake other duties appropriate to this level of classification which contribute to the operation of the organisation.

Specific competencies include but are not limited to the following.

• Advanced clinical judgement and critical thinking, applying evidence-based reasoning to support safe, ethical, and high-quality trial coordination across a complex clinical portfolio.
• Demonstrated leadership and supervisory capability, with the ability to guide, support, and develop a team of clinical trials coordinators in a dynamic research environment.
• Collaborative and inclusive approach to leadership, contributing positively to team culture and supporting the professional development of others.
• Strong organisational and operational management skills, with the ability to oversee multiple concurrent trials and coordinate team activity effectively.
• Adaptability and sound judgement in a dynamic environment, with the ability to manage competing priorities and respond constructively to change while maintaining quality and consistency.
• Clear and effective communication, engaging with authority and professionalism with patients, clinicians, sponsors, and multidisciplinary stakeholders.
• Commitment to quality and governance, with demonstrated accountability for accurate documentation, compliance with Good Clinical Practice, and adherence to organisational standards.
• Patient-centred focus, modelling respectful, compassionate engagement with patients and families throughout the clinical trial journey.
• Demonstrated commitment to maintaining a safe and healthy workplace by complying with Work Health and Safety (WHS) legislation, organisational policies and safety frameworks, and contributing to a culture that prioritises safety, quality, and the wellbeing of staff, patients, and research participants.

Specific qualifications include, but are not limited to, the following.

Essential

• A Tertiary Qualification in Nursing
• Hold current registration, or be eligible for registration, as a nurse with the Nursing and Midwifery Board of Australia through the Australian Health Practitioner Regulation Agency (AHPRA).

Desirable

• Tertiary qualifications in project management
• Understanding of the National Clinical Trials Governance Framework and the application of relevant National Safety and Quality Health Service (NSQHS) Standards to clinical trial delivery.

Specific experience includes, but is not limited to, the following.

Essential

• A minimum of five years’ full-time equivalent experience as a Registered Nurse.
• Demonstrated experience in clinical trials coordination, preferably within a haematology, oncology, or similarly complex clinical environment.

Desirable

• Project Management experience
• Experience or knowledge of the CHS Exceptional Care Framework, and other relevant CHS safety, quality and clinical governance frameworks.

Appointment to this position is conditional on being granted and retaining appropriate clearances.

• Pre-employment National Police Check.
• Comply with Canberra Health Services Occupational Assessment, Screening and Vaccination policy.

All employees are required to:

• adhere to the Canberra Health Services Values and the ACT Public Service Code of Conduct
• act in accordance and comply with all relevant Safety and Quality policies and procedures.
• Comply with all relevant clinical and/or competency standards.

CHS is leading the drive to digitally transform health service delivery in Australia through the implementation of a territory wide Digital Health Record. Computer literacy skills are required which are relevant to this role as you will be responsible for completing required documentation and becoming a proficient user of the Digital Health Record and/or other Information Technology systems; once proficient, you will need to remain current with changes, updates, and contingencies.

These are the key selection criteria for how you will be assessed in conjunction with your resumé and experience.

1. Demonstrated nursing experience with the ability to apply advanced clinical knowledge and judgement in clinical trial and research settings, including experience coordinating clinical trials within haematology, oncology or a similarly complex clinical environment.
2. Demonstrated supervisory or team leadership experience, including the ability to guide, develop and support clinical staff; contribute to recruitment, onboarding, staff performance and capability processes; and provide training and troubleshooting support to a multidisciplinary coordination team in collaboration with senior management.
3. Exceptional interpersonal and communication skills, with a proven ability to build effective working relationships with patients and families, investigators, sponsors, monitors and multidisciplinary teams, communicate with authority and sensitivity, and manage complex or challenging discussions constructively.
4. Demonstrated ability to lead the operational management of a complex clinical trials portfolio, including overseeing end-to-end trial coordination, assessing and monitoring trial feasibility, unit capacity and portfolio sustainability, managing competing priorities across multiple concurrent studies, and maintaining compliance with ethical, regulatory and governance requirements. This includes high-level digital literacy and attention to detail in documentation, data integrity and reporting.
5. Demonstrates understanding of, and adherence to, safety and quality standards, Work Health and Safety and the positive patient experience. Displays behaviour consistent with CHS’s values of Reliable, Progressive, Respectful, and Kind.

The following work environment description outlines the inherent requirements of the role and indicates how frequently each of these requirements would need to be performed. Please note that the ACT Public Service is committed to providing reasonable adjustments and ensuring all individuals have equal opportunities in the workplace.

Administrative	Frequency
Telephone use	Frequently
General computer use	Frequently
Extensive keying/data entry	Frequently
Graphical/analytical based	Frequently
Sitting at a desk	Frequently
Standing for long periods	Occasionally

Travel	Frequency
Frequent travel – multiple work sites	Occasionally
Frequent travel – driving	Occasionally

Physical demands	Frequency
Distance walking (large buildings or inter-building transit)	Frequently
Working outdoors	Never

Psychosocial demands	Frequency
Distressed People e.g. Emergency or grief situations	Never
Aggressive & Uncooperative People e.g. drug / alcohol, dementia, mental illness	Never
Unpredictable People e.g. Dementia, mental illness, head injuries	Never
Restraining e.g. involvement in physical containment of clients/consumers	Never
Exposure to Distressing Situations e.g. Child abuse, viewing dead / mutilated bodies; verbal abuse; domestic violence; suicide	Never

Specific hazards	Frequency
Working at heights	Never
Exposure to extreme temperatures	Never
Operation of heavy machinery e.g. forklift	Never
Confined spaces	Never
Excessive noise	Never
Low lighting	Never
Handling of dangerous goods/equipment e.g. gases; liquids; biological.	Never
Slippery or uneven surfaces	Never

Manual handling	Frequency
Lifting 0 – 9kg	Occasionally
Lifting 10 – 15kg	Never
Lifting 16kg+	Never
Climbing	Never
Running	Never
Reaching	Occasionally
Kneeling	Occasionally
Foot and leg movement	Occasionally
Hand, arm and grasping movements	Occasionally
Bending/squatting	Occasionally
Bend/Lean Forward from Waist/Trunk twisting	Occasionally
Push/pull	Occasionally
Sequential repetitive movements in a short amount of time	Occasionally