AddressAbout us:
Operating for more than 30 years, CMAX is Australia’s longest running and most experienced clinical trial units conducting successful world-leading research for local and international clients, specialising in a range of early-phase trials and first-in-human studies.
We are proud to be a key contributor in the advancement of global medicines and technologies - from vaccines and pain control to early warning bio-devices and hormone replacement therapies, these are just a few of the many research areas for which CMAX has provided clinical trial services.
Employing more than 300 staff, CMAX is a 78-bed clinical trials unit, with a database of more than 50,000 clinical trial participants, and utilising state-of-the-art facilities, we are primely positioned, opposite the Royal Adelaide Hospital and part of the Adelaide BioMed City precinct.
About the role:
Reporting to the Study Start-Up Manager, the Study Start-Up Specialist will be a fulltime position providing support to the study through the planning and execution of start-up activities for awarded clinical trials enabling the conduct of high quality study conduct.
The Study Start-Up Specialist will support information flow between Business Development, Clinical Operations and will coordinate the transition of newly awarded studies to the Clinical Project Management team. This role is pivotal in study start-up activities from the time of study award through to HREC/IRB approval. Some Business Development work may also be undertaken, utilising costing models and assessing feasibility of proposed studies.
The Study Start-Up Specialist will provide positive support and guidance across multiple CMAX departments and play an active role in promoting a culture of excellence and continuous improvement within the team and liaise, build and maintain strong relationships with sponsors, CROs and their representatives.
Key responsibilities include:
- Draft timelines for study start-up activities;
- Prepare and/or review key clinical study documentation including the Study Protocol and Participant Information Form/Informed Consent Form as directed by the relevant CMAX Manager;
- Assist in the preparation and tracking of Human Research Ethics Committee/Independent Review Board (HREC/IRB), Research Governance submissions and other regulatory documentation as delegated by the Clinical Project Manager;
- Participate in initial discussions/meeting with study sponsors and or CROs, as required;
- Work with Sponsors, CROs and Investigators to respond to IRB/HREC comments, amending key documents as required and enabling timely submission for approval;
- Ensure correct versions of study documentation are distributed for review by key study personnel within the required start-up timelines and that feedback is collated and communicated in a consistent and complete manner;
- Supporting completion of study legal agreements including Confidentiality Agreements, Letters of Intent, Clinical Trial Research Agreements, work orders and sub-contracts;
- Update CMAX documentation with details of new study awards, including but not limited to, protocol allocation logs, study start up lists and study folders;
- Provide relevant start-up and handover information (including key study start-up milestones) to CMAX clinical staff to enable smooth start-up of studies, including the allocated CMAX study team;
- Provide assistance and study support to other clinical staff when required as directed by the relevant CMAX Manager.
- Actively promote a commitment to excellence and continuous improvement across the organisation;
- Actively participate in the generation, review and update of CMAX Standard Operating Procedures and other continuous improvement initiatives.
About you:
- Tertiary qualifications in an appropriate science or other relevant area;
- Working knowledge of ICH/GCP and the local regulatory framework;
- Demonstrated experience in clinical research, particularly in reviewing key study documentation and preparing ethics submissions;
- Effective planning and organisational skills, with the ability to prioritise and work on a number of studies concurrently;
- Demonstrated competence in the personal attributes of attention to detail, problem solving, flexibility, and time management;
- Excellent written and oral communication skills;
- Competent with the use of Microsoft Word, Excel, Powerpoint.
If you enjoy a challenge, working in a fast-paced environment and have an interest in innovation of healthcare, please apply by attaching your application letter and CV via the Apply Now function. Applications will close on Friday 12 July 2024.
Only candidates who have the right to work unrestricted in Australia will be considered for this position.
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.
