Clinical Research Associate

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.

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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.

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

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

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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.

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

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• 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.
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• 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.
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• Monitor (remote and on-site) and co-monitor the sites to verify data accuracy by conducting SDV as per Monitoring Plan.
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• Track and maintain site status and update.
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• Coordinate the flow of information from site to CPM
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• Ensure that the IMP is stored under appropriate protocol-specified conditions
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• Assure completeness of CRFs, query resolution, and Investigator Site File at the site and subject compliance to study protocols
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• Resolution of queries within timelines
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• Motivate the site staff to deliver study activities efficiently
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• Works with Study Start-up Group and site staff to obtain regulatory (IRB/IEC) approval of study-specific documents.
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• Manage CSR review and sign-off by investigators.
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• Support resolution for any study audit observations.
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• Perform site-level reconciliation of study material (including the IP) and site-level finance reconciliation.
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• Ensure all SAEs/AEs are being appropriately managed.
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• Ensure availability of all applicable Safety Reports, CIOMS, and IND letters on ISF, followed by regular reconciliation of EC submission and acknowledgment.
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• Archival with an inventory list of source documents, CRFs, and CTM Other at the site.
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• Ensure all unused trial supplies are accounted for. Close down trial sites on completion of the trial.
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Requirements:

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