Senior Study Coordinator

About Us:

Fusion Clinical Research (Fusion) is a dynamic Phase I-III clinical trials organisation based at Norwood, SA. Fusion is committed to advancing medical research, enhancing patient care and driving innovation in the healthcare landscape.

Fusion provides an ideal setting for the enrolment of patients with conditions usually managed by their family doctor and an ability to service vaccine trials of all phases.

By partnering with multiple General Practitioners (GPs) and specialists within South Australia, Fusion is able to search GP databases for specific patient populations and inclusion/exclusion criteria to find the right patients for matching trials. Through these established physician-patient relationships, we maintain continuity of care close to patients' homes promoting high participation and trust.

Fusion's Vaccine Arm is experienced in running vaccine trials of all phases and boasts a database of over 8,000 participants, engaged and interested in vaccines to enrol from.  This allows Fusion to deliver high throughput vaccine studies and rapid enrolment timelines for a variety of population groups and vaccine targets.

Fusion is a subsidiary of CMAX Clinical Research, one of Australia's largest and most experienced Phase I -II clinical trial units.

About the role:

Fusion is seeking a Clinical Research Team Lead (Senior Study Coordinator) to plan coordinate, monitor, perform and provide leadership for study activities associated with clinical trials to a high standard of quality and in accordance with Fusion and CMAX Standard Operating Procedures (SOPs) and relevant regulations and guidelines. Lead, manage and supervise the Fusion site study team to achieve study objectives.

The Clinical Research Team Lead will make a substantial contribution to the conduct and quality of clinical studies by working with the Clinical Research Director in a range of important functions ensuring that studies are conducted to a high standard of quality and consistent with Fusion SOPs and other relevant regulations and guidelines.

As a senior and experienced team member, this will involve effective leadership and direct participation in the planning, organising, communicating, implementing, monitoring, evaluating and coordination of Fusion Team objectives. This will include the provision of leadership, supervision and direction to other team members by actively participating in the monitoring and development of the Fusion Team performance and playing an active role in promoting a culture of excellence and continuous improvement within the team.

Responsibilities may include:

• Lead and monitor the performance of supervised Fusion Team members and provide regular constructive feedback, identify and facilitate training and development needs;
• Actively contribute to the identification, design and delivery of staff training;
• Assist the Clinical Research Director and other relevant stakeholders, in the establishment of effective Fusion Key Performance Indicators (KPI's) and the monitoring and reporting of these as required;
• Participate as an effective and productive member of the Fusion Leadership Team;
• Contribute to the provision of a safe and productive team culture and work environment;
• Demonstrate a commitment to own learning and development and actively contribute to a culture of learning at Fusion;
• Monitor Human Research Ethics Committee/Independent Review Board (HREC/IRB) submissions and documentation;
• Perform quality control checking of pre, on and post-study trial documentation;
• Assist with the planning and conduct of study specific audits to ensure that studies are performed, and data being generated/recorded in accordance with applicable Australian and overseas regulatory guidelines (including ICH-GCP), the relevant organisational Standard Operating Procedures and with the Study Protocol;
• As a senior member of the Fusion Team, actively model and promote a culture of excellence.

About you:

• Strong working knowledge of standards, procedures and regulations relating to the conduct of clinical studies, including ICH GCP;
• Demonstrated experience in clinical research or proven competency to work effectively in this area;
• Well developed interpersonal skills, including verbal and written communications skills and the ability to engage positively with a diverse range of staff and stakeholders;
• Sound knowledge of, and the ability to apply, effective project management skills and practices to the conduct of clinical studies;
• Ability to provide positive guidance, feedback, leadership and support to team members and to achieve successful outcomes based on effective team work;
• Well developed planning and coordination skills and the ability to assist in developing, monitoring and reviewing clinical study project plans;
• Demonstrated competence in the personal attributes of leadership, initiative, flexibility, time management and attention to detail;
• Proven ability to demonstrate sound, evidence based judgement and decision-making skills and the ability to solve problems in a constructive manner;
• Well developed analytical, interpretive and reasoning skills and the ability to work with complex and/or large volumes of data;
• Sound understanding of the principles and practices applying to quality and continuous improvement within a clinical research environment.

Fusion Clinical Research predominantly operates within business hours Monday to Friday.

Successful applicants will be required to attend a mandatory 4-day induction followed by specific training. Training for all clinical assessments will be provided.

If you have experience in clinical trials or are looking for a rewarding career in clinical research, please apply by attaching your application letter and CV via the Apply Now function, applications close on 21 September 2025.

Only experienced candidates with approved rights to work full time without restrictions in Australia will be shortlisted for this role.

Please note that we may be conducting interviews during the advertisement period and retain the right to withdraw the advert should we select a successful applicant prior to the closing date.