Clinical Research Associate

Upsilon Global; Australia; Remote; AUD 90,000 - 120,000; Full time

Job summary

Upsilon Global is expanding its clinical operations in Australia, building a core team to support a growing trial portfolio focused on oncology and related indications. This permanent, homebased role offers exposure to site management, regulatory approvals, and end-to-end study coordination across multiple trials.

The successful candidate will have 3–5 years in CRA roles, strong GCP knowledge, and hands-on experience with data management tools such as Veeva, Medidata RAVE, and Oracle, with

Qualifications

• Graduate or post-graduate in science, medical or pharmaceutical field.
• Diploma or degree in Clinical Research.
• Approximately 3–5 years of experience as a Clinical Research Associate.
• Fundamental knowledge of GCPs and clinical study development processes.
• Proficient with clinical data management tools and MS Office.

Responsibilities

• Assess feasibility of conducting trials at study sites including site infrastructure and patient population.
• Conduct site qualification, initiation, monitoring and close-out visits per protocol.
• Monitor data accuracy via SDV and maintain site status updates.
• Coordinate information flow from site to CPM and ensure proper drug storage.
• Ensure CRFs, queries, and ISF/site files are complete and compliant.
• Support resolution of audit observations and study close-out activities.
• Reconcile study materials and IP at site; manage site-level finance reconciliation.
• Travel approximately 70% of working time to manage sites.

Skills

Attention to detail

Communication skills

Problem-solving

Travel willingness

Team collaboration

Education

Clinical Research Diploma/Degree

Tools

Veeva

Oracle

Medidata RAVE

MS Projects

MS Office

Job description

Upsilon Global are supporting the growth of an exciting US-based CRO. Using cutting-edge, AI-based technology as a key part of their service, this CRO has successfully supported 100+ phase I-III trials across a range of therapeutic areas.

After a number of years operating across Australia and New Zealand through the use of freelance CRAs, they are now looking to stabilise their presence and build a core clinical operations team to support their expanding clinical trial portfolio across the region.

The primary requirements are a passion for clinical research, an organised approach to your work and passion for learning and development.

The portfolio primarily covers oncology, sleep medicine/disorders, respiratory, gastroenterology and hepatology, so prior experience in these indications would be beneficial

This is a fantastic opportunity for anyone seeking the opportunity to be part of a smaller/growing team where the range of responsibility is vast and the impact of your work can be seen.

• Start Date: Soon as Possible
• Contract Type: Permanent contract
• Company type: Mid-sized CRO
• Therapeutic Area: Oncology
• Location: Australia, homebased

Key Responsibilities:

• Determine the feasibility of conducting and managing clinical trials at study sites, considering factors such as the site's infrastructure, staffing, patient population, overseeing the recruitment of patients, the collection of data, and reporting and identification of PD’s, AE’s and SAE’s.
• Conduct clinical study visits (i.e., Site Qualification Visit, Site Initiation Visit, Interim Monitoring Visits, and Close-Out Visit) to ensure that the study is conducted according to protocol and that all data is collected accurately.
• Monitor (remote and on-site) and co-monitor the sites to verify data accuracy by conducting SDV as per Monitoring Plan.
• Track and maintain site status and update.
• Coordinate the flow of information from site to CPM
• Ensure that the IMP is stored under appropriate protocol-specified conditions
• Assure completeness of CRFs, query resolution, and Investigator Site File at the site and subject compliance to study protocols
• Resolution of queries within timelines
• Motivate the site staff to deliver study activities efficiently
• Works with Study Start-up Group and site staff to obtain regulatory (IRB/IEC) approval of study-specific documents.
• Manage CSR review and sign-off by investigators.
• Support resolution for any study audit observations.
• Perform site-level reconciliation of study material (including the IP) and site-level finance reconciliation.
• Ensure all SAEs/AEs are being appropriately managed.
• Ensure availability of all applicable Safety Reports, CIOMS, and IND letters on ISF, followed by regular reconciliation of EC submission and acknowledgment.
• Archival with an inventory list of source documents, CRFs, and CTM Other at the site.
• Ensure all unused trial supplies are accounted for. Close down trial sites on completion of the trial.

Requirements:

• A graduate or post-graduate with science &/or medical &/or pharmaceutical back ground.
• Diploma &/or degree in Clinical Research.
• Approximately 3-5yr Experience as Clinical Research Associate
• Fundamental knowledge and good understanding of GCP’s, clinical study development process, and logistics.
• Great and consistent attention to detail and follow through on commitments.
• Excellent verbal and written communication skills.
• Good understanding of applicable guidelines governing clinical trials.
• Proficient in clinical data management tools (Veeva, Oracle, Medidata RAVE), Microsoft Office (Word, Excel, PowerPoint), and MS Projects.
• Ability to manage and maintain information and documentation in CTMS, eTMF, and various other systems as appropriate as per timelines.
• Ability to travel approximately 70% of working time.
• Ability to contribute to developing clinical protocols, informed consent forms, and case report forms.
• Problem-solving skills with the ability to identify, assess and resolve site performance, quality, or compliance problems.
• Exceptional interpersonal skills to develop strong site relationships through all trial phases.