Clinical/Medical Research (Healthcare & Medical)
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, we are committed to advancing medical research, enhancing patient care, and driving innovation in the healthcare landscape.
About the role:
We are seeking a Clinical Research Coordinator for our Fusion Team.
This role will be offered with an initial 12-month fixed term fulltime contract with a view to extend. Hours of work will be general business hours with the need to be flexible for occasional after hours and weekend study activities.
Study activities will occur at our Fusion Norwood Hub site and GP Practices within our network.
Reporting to the Clinical Research and Hub Manager, the Clinical Research Coordinator is involved in the planning, organising, efficient execution, coordinating and monitoring of the clinical trial, in accordance with the protocol, ICH/GCP guidelines and applicable regulatory guidelines and CMAX SOPs, whilst ensuring sponsor/CRO milestones are adhered to.
A key success for this role will be contributing to the development and maintenance of effective relationships with a range of internal and external stakeholders, including current and potential sponsors and/or their representatives.
The Clinical Research Coordinator will also provide positive support and guidance to other study team members and play an active role in promoting a culture of excellence and continuous improvement within the team.
Key responsibilities include:
- Track and maintain HREC approval, assisting the Clinical Research and Hub Manager and Clinical Trials Manager in preparing submissions and notifications;
- Review key clinical study documentation including the Study Protocol, developing training material for site staff;
- Liaise with pharmacy and vendors relating to IP management and accountability;
- Attend project meetings, track deliverables and share best practice;
- Liaise with CROs and Sponsors to facilitate monitoring and close out visits activities, ensuring all items for follow up are addressed;
- Participate in Site Selection Visits, Kick Off Meetings and Site Initiation Visits;
- Ensure quality control checks are performed on all documentation and that continuous improvement measures are implemented as needed;
- Liaise with vendors and internal departments to ensure all study requirements and responsibilities are effectively communicated and executed.
About you:
- Tertiary qualifications in an appropriate science or other relevant area;
- 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 and negotiation skills;
- Ability to provide effective guidance and support to other team members;
- Ability to work as an effective member of the team and to use initiative and drive to support the Clinical Research and Hub Manager and other key internal stakeholders;
- Sound 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 initiative, flexibility, time management and attention to detail.
If you are looking for your next challenge, please apply by attaching your application letter and CV via the Apply Now function, applications close on Friday 04 October 2024.
Only 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.
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