Clinical Trial Nurse Manager

Base Pay Range A$130,000.00/yr - A$140,000.00/yr Clinical Trials Nurse Manager JM Clinical is an emerging Australian clinical trials site specialising in immunology and gastroenterology research. Our mission is to accelerate the development of novel therapies by providing high‑quality, compliant, and patient‑centred clinical trial services. We’re a small and highly capable team. We move fast, think smart and get things done. Every person here has real ownership, and every role has impact. We are a genuinely nice group of people who care about our work and each other. Role Overview The Clinical Trials Nurse Manager leads the end‑to‑end delivery of GI‑focused clinical trials at the site level, combining operational leadership with hands‑on clinical and laboratory execution. The role is responsible for trial planning and coordination, study start‑up, protocol implementation, participant recruitment, sample collection, and in‑house blood processing (including centrifuging and aliquoting). This position ensures participant safety, regulatory and ethics compliance, clinical data quality, and continuous improvement of trial processes in line with Good Clinical Practice (GCP). The role collaborates closely with Principal Investigators, Sub‑Investigators, research nurses, research assistants, and external partners (CROs, laboratories, and sponsors). Prior clinical trial site or CRO experience is essential. Laboratory capability is highly desirable to support resilient and efficient study workflows. This is a 12‑month fixed‑term contract providing maternity leave cover, reporting to the Managing Director. Key Responsibilities Clinical & Participant care Deliver and oversee high quality care to trial participants, including administering investigational products and monitoring health status. Our ideal candidate can also collect, handle, centrifuge, aliquot, and process blood samples per protocol. Lead participant education and engagement on protocols, study visits, treatment adherence, and potential side effects. Act as the primary escalation point for clinical concerns, adverse events, and protocol deviations, ensuring timely triage, sponsor communication, and compliant documentation. Maintain ownership of participant safety workflows, including coordination of safety reporting and deviation management. Participant Recruitment and Retention Conduct participant screening, eligibility assessments, and informed consent discussions. Maintain accurate recruitment logs and proactively manage enrolment targets and timelines. Monitor participant retention and follow‑up compliance, implementing engagement strategies to reduce withdrawals. Support marketing or awareness activities to promote trial participation where appropriate and approved. Trial Operations and Site Management Manage operational delivery of assigned trials, ensuring adherence to timelines, budgets, and quality standards. Coordinate start‑up, initiation, conduct, and close‑out activities, including logistics and documentation. Oversee day‑to‑day scheduling, staffing, and workflow to maintain efficient site operations. Liaise with investigators, sponsors, CROs, and vendors to facilitate trial execution and resolve issues promptly. Track site performance metrics (recruitment, data entry, monitoring findings) and implement improvement actions as needed. Ethics, Quality, and Regulatory Compliance Ensure adherence to GCP, TGA, NHMRC, and HREC requirements. Prepare and maintain ethics submissions, safety reports, and amendments. Monitor compliance with SOPs and sponsor requirements, identifying and resolving quality issues. Maintain audit readiness and support both internal and external audits. Research Development and Business Growth Contribute to feasibility assessments and operational input for new studies. Review protocols to identify resource needs, operational risks, and process improvements. Represent JM Clinical at sponsor meetings, investigator sessions, and site teleconferences. Support the growth of JM Clinical’s research portfolio and strengthen relationships with investigators and referring clinicians. Skills & Qualifications Registered nurse with 5+ years clinical trial experience at site or CRO sponsor facing roles. Strong understanding of GCP, HREC processes, and TGA regulatory environment. Experience coordinating patient requirement pathways and safety escalation. Ability to work independently while fostering collaboration within a multidisciplinary team. Practical experience in clinical trial blood sample workflows (e.g., processing clinical trial bloods, lab sample handling). Full time. 12‑month fixed‑term maternity leave cover contract. Location: QEI Woolloongabba, car parking available. Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Health Care Provider #J-18808-Ljbffr