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 45,000 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:
CMAX is seeking Clinical Trial Coordinators/Study Coordinators to work collaboratively in the study team to facilitate the successful execution of Clinical Trials. These positions are permanent fulltime positions, and ideal candidates must be able to work flexible hours including occasional after hours and weekend work. Extensive experience of more than 3 years at Coordinator level will be considered for Study Coordinators level opportunity and relevant remuneration level.
Reporting to the Clinical Project Manager (CPM), the Clinical Trial Coordinator/Study Coordinators are involved in the planning, organising, efficient execution and monitoring of the Clinical Trial in accordance with the protocol, ICH/GCP guidelines and applicable regulatory guidelines and CMAX Standard Operating Procedures (SOPs), whilst ensuring sponsor/CRO milestones are adhered to.
This role will be primarily responsible for:
- Review key clinical study documentation including the Study Protocol, developing training material for site staff;
- Prepare source documentation;
- Maintain the Investigator Site file;
- Liaise with Clinical Research Associates to facilitate monitoring and close out visits activities ensuring all items for follow up are addressed;
- Liaise with pharmacy and vendors relating to IP management and accountability;
- Liaise with vendors and internal departments to ensure all study requirements and responsibilities are effectively communicated and executed;
- Attend project meetings and study coordinator meetings to track deliverables and share best practice;
- Participate in on-study activities as required;
- Ensure results of protocol specified procedures and assessments are reviewed in accordance with CMAX SOPs;
- Ensure biological samples are processed, stored and tracked in accordance with CMAX SOPs;
- Participate in 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;
- Track and maintain HREC approval, assisting the CPM in preparing submissions and notifications;
- Appropriate escalation of issues and protocol deviations in accordance with CMAX SOPs.
About you:
- Tertiary qualifications or equivalent relevant training and experience either within a health/science related discipline and/or project management is highly desirable;
- Sound knowledge of standards, procedures, protocols and regulations relating to the conduct of clinical studies, including Good Clinical Practice (GCP) preferred;
- Demonstrated hands on experience within the clinical research industry in similar role/team;
- Effective time management, planning and organisational skills, with the ability to prioritise and work on a number of studies concurrently;
- Well developed written and oral communication skills and the ability to interact effectively with a range of people; and to use initiative/show leadership capability to support the Clinical Project Manager and other key internal stakeholders;
- Proven ability to work with accuracy and apply strong attention to detail;
- Demonstrated competence in the personal attributes of problem solving, flexibility, and a high level of emotional intelligence;
- Competent in using the Microsoft suite of programs including Word, Excel, Outlook, databases and other relevant tools.
If you are looking for a challenging and exciting opportunity, then please apply by attaching your application letter and CV via the Apply Now function, applications close on Friday 31 May 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.
