CMAX Clinical Research – Kensington and Norwood SA
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: Reporting to the Clinical Research Team Lead, the Clinical Research Officer contributes to the conduct of clinical trials to a high standard and quality by assisting in the planning, coordination and operation of studies as a member of a Study Team and will undertake a range of tasks across pre, post and 'on study' clinical trials.
Hours of work will be permanent fulltime within business hours with the need to be flexible for occasional after hours and rarely for weekend study activities. Study activities will occur at our Fusion Norwood Hub site as well as at various GP Practices across our network, this will require you to be willing and able to travel between various sites.
This is an entry level position and graduates from relevant science related studies are encouraged to apply.
Key responsibilities include: Prepare key clinical study documentation including the screening book, source book and other source documentation, printing and binding study documents, photocopying, etc;Participate in activities relating to the entry, review, and checking of collected data/results;Administration of clinical study and/or safety reports as directed;Assisting in the review and updating of Standard Operating Procedures (SOPs) and/or other quality assurance (QA) and continuous improvement activities.Ensure that required equipment and documentation is readily available for the number of screening appointments scheduled on any given day;Ensure that participants are provided with required information about the clinical trial, provide informed consent forms and complete all relevant documentation;Ensure that Screening Numbers have been allocated and that relevant details in the Volunteer Screening Log and Screening Source Book have been accurately completed;Ensure the effective completion, documenting and couriering of pathology samples;Undertake pre and post-screening tasks as required;Perform all data entries in source documents and subject Case Report Forms (CRFs) as required;Perform and/or witness subject dose administration activities as required;Competently and safely perform all clinical study procedures included in the Clinical Training Program, such as vital signs, electrocardiographs, alcohol breath testing, blood collection from cannula, etc;Ensure that biological samples are processed, stored and tracked in accordance with relevant protocols, SOPs and laboratory manuals;Handle and track adverse event reports in accordance with the Study Protocol;Assist with the collation and confirmation of laboratory results reported, and liaise with vendor if laboratory results are not completed or further testing is required;Track and assist with the oversight and urgency of escalation of laboratory results for Principal Investigator or delegate review;Follow up and review of Principal Investigator or delegate reviewed laboratory results and scheduling of required repeats.About you: Tertiary qualifications in an appropriate science or other relevant area;Current drivers licence and own vehicle;Capability to undertake successful completion of our internal Clinical Training Program, inclusive of taking of vital signs, electrocardiographs, alcohol breath testing, blood collection from cannula, etc;Well developed written and oral communication skills and the ability to interact effectively with a range of people;Proven ability to work with accuracy and apply strong attention to detail;Working knowledge of standards, procedures and regulations relating to the conduct of clinical studies, including ICH GCP will be highly regarded;Demonstrated experience in clinical research or other related health industry experience will be highly regarded.Successful applicants will be required to attend a mandatory 5-day induction at our CMAX location in the CBD followed by specific training. Training for all clinical assessments will be provided.
If you have experience in the health industry and/or are looking for a rewarding career in clinical research, please apply by attaching your application letter and CV via the Apply Now function, applications close by COB 09 Dec 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.
#J-18808-Ljbffr