Principal Investigator • Clinical Trials • Multiple Therapeutic Areas • Melbourne based Our client has decades of experience conducting clinical trials in multiple therapeutic areas, providing the best outcomes for participants and sponsors. Their network of sites in Sydney and Melbourne conduct Phase I to Phase IV trials in purpose built out-patient facilities. Working closely with their sponsor’s teams and understanding their sponsor’s objectives allows them to implement a tailored approach to meet their clinical trial requirements. Reporting to the Site Medical Lead you will be responsible for the conduct of a clinical trial at site and be accountable to the company and the clinical trial sponsor. You will support a culture of responsible clinical trial conduct and provide oversight and mentorship to the clinical trial team. Your focus is on safety, keeping in line with protocol requirements, GCP, and the company’s expectations. The Role Clinical Operations ▪ Consult with the OM to optimise recruitment opportunities for all participants ▪ Collaborate with the Clinical Trial Team to ensure adequate resources are available to conduct the trial ▪ Maintain our exceptional collaborative, supportive and friendly culture ▪ Provide clinical input into trial feasibility assessments and protocol development. ▪ Monitor trial progress and participant outcomes, ensuring timely documentation and reporting. ▪ Participate in recruitment and retention strategies for study participants and investigators. ▪ Provide mentorship to Clinical Trial Investigators and support to Principal Investigators Regulatory and Quality assurance ▪ Ensure all regulatory approvals and documentation are in place prior to trial commencement and that conditions of any approvals are adhered to during the trial. ▪ Maintain compliance with Good Clinical Practice (GCP), HREC requirements, and sponsor protocols. ▪ Oversee audit and inspection readiness and manage corrective and preventative actions (CAPAs). ▪ Uphold ALCOA+ documentation standards and contribute to continuous quality improvement initiatives. ▪ Undertake ongoing training to maintain competency as a Principal Investigator. ▪ Protect the participants’ welfare during the clinical trial, by ensuring that the necessary clinical care is provided to study participants ▪ Comply with requirements for consent as outlined in the trial protocol ▪ Inform the participant’s primary physician about the participant’s involvement in the project ▪ Retain the participant on a clinical trial (including follow-up with primary care physician) ▪ Ensure a lay summary of the trial results is disseminated to participants ▪ Provide reports to the Human Research Ethics Committee (HREC) on adverse events, proposed amendments to the protocol and any information that might affect the continued ethical and scientific acceptability of the project ▪ Participate in relevant Safety Committees when invited Business and Strategic Support ▪ Contribute to the development and execution of the organisation’s clinical research strategy. ▪ Provide insights and metrics to the Site Medical Lead to support business performance and planning. ▪ Actively promote the organisation’s capabilities to sponsors and stakeholders to attract new studies. ▪ Participate in performance review processes and contribute to team OKRs. ▪ Support the design and implementation of technology platforms that enhance trial efficiency and data quality. ▪ Act as a consultant for study feasibility reviews ▪ Perform a formal evaluation of study processes at end of study, with the view to improving efficiency and effectiveness ▪ Practice and promote our company values Stakeholder Engagement ▪ Promote the site capabilities and performance through positive engagement with Sponsors, Clinical Research Organisations, regulatory authorities and other stakeholders ▪ Support and mentor junior doctors to ensure high-quality clinical conduct and professional development. ▪ Use diplomacy and professionalism when managing sponsor queries and staff-related matters. ▪ Build and maintain a close relationship with our recruitment partners ▪ Act as an ambassador for the company by increasing the awareness of our abilities and accomplishments ▪ Attend conferences when required Optimising Efficiency ▪ Embrace a customer intimate focus, to rapidly provide quality data to sponsors ▪ Tailor pre-screening and trial activities to align with protocol requirements and business needs. ▪ Demonstrate adaptability to meet the evolving needs of trials, sponsors, and the organisation. ▪ Suggest and support improvements to current technology platforms and workflows. ▪ Conduct post-study evaluations to identify opportunities for process improvement and increased effectiveness STRENGTHS ▪ Demonstrate leadership qualities to guide and manage a clinical trial. ▪ Demonstrate an adaptive communication style to ensure other people’s understanding. ▪ Demonstrate compassion and empathy for your patients and colleagues. ▪ Possess a natural curiosity and continually seek out new information to enhance your personal and professional development. ▪ Maintain a sense of optimism and composure when addressing any issues, inspiring others to do the same ▪ Be solution focussed through collaboration and open-minded thinking. ▪ Demonstrate alignment with the company’s business goals SKILLS AND QUALIFICATIONS ▪ Undergraduate Medical Degree ▪ Previous role as a Clinical Trial Principal Investigator or significant experience as a Clinical Trial Investigator in a Clinical Trial Centre ▪ Unrestricted General and/or Specialist Registration with AHPRA ▪ Current Medical Indemnity Insurance ▪ Australian Citizenship or Permanent Residency