Clinical Research Team Lead

About Us:

Operating for over three decades, CMAX Clinical Research is one of Australia’s largest and most experienced Phase I-II clinical trial units conducting successful world-leading research for local and international clients, specialising in a range of early-phase trials and first-time-in-human studies. 

Our subsidiary, Fusion Clinical Research (Fusion), is a dynamic phase II-IV Clinical Research organisation using a Hub and Spoke operational model. Fusion utilises multiple GP clinic networks and associated specialist clinics to undertake clinical trials. 

Fusion’s mission is to provide participants with convenient access to a wide range of trials and medications within their trusted GP or Specialist practice, while also enabling pharmaceutical and device companies to cover a range of studies from vaccinations to complex medical conditions.

At Fusion Clinical Research we are committed to advancing medical research, enhancing patient care, and driving innovation in the healthcare landscape.

About the role:

Fusion is seeking a Clinical Research Team Lead 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 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 and Hub Manager 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 and Hub Manager, 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;
• Demonstrated knowledge of, and ability to work successfully within, rigorous standards, protocols and regulations, including ICH GCP preferred;
• 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;
• Ability to work as an effective member of a leadership team and to use initiative and drive to support supervised staff and other key internal stakeholders;
• 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. 

This position is based at Fusion Clinical Research, Norwood and will involve some travel to associated GP locations. 

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 19 July 2024.

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.