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This range is provided by Hlx Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
A$150.00/yr - A$175.00/yr
We're seeking a Senior Clinical Research Associate (CRA) for my client, a tech-enabled CRO that is transforming how technology is used in clinical trials with AI. In this role, the CRA will oversee clinical trial sites within a designated region, ensuring compliance with the Monitoring Plan, protocol, Good Clinical Practice (GCP), and local regulations. Acting as the primary point of contact for assigned sites, they will facilitate communication between site personnel and the client. Key responsibilities include conducting site visits, managing essential document collection and review, and preparing detailed trip reports to summarize monitoring activities.
Essential Functions of the job:
* Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH GCP, protocol, and company SOP compliance.
* Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions
* Identifies potential factors which might affect subject safety and clinical data integrity, immediately communicates/escalates serious issues to the project team and develops action plans.
* Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
* Verifies site processes to obtain informed consent have been adequately performed and documents for each subject
* Assess site processes, conducts source document review, and verifies site compliance with data entry requirements according to the Monitoring Plan
* Performs Source Data Review/Source Data Verification for assigned clinical trial sites
* Reviews investigational product inventory, reconciliation and storage at trial sites, ensure GCP guidelines are followed
* Reviews the Investigator Site File for accuracy and completeness
* Provides site and regional metrics into trackers to support project-level report generation
* Understands project scope, budgets, and timelines for own activities in the clinical operations team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
* Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
* Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
* Provides guidance at the site level towards audit readiness standards and supports preparation for audit and required follow-up actions.
Qualifications:
* Minimum of 2 years of Clinical Monitor/CRA experience in a biotech, pharmaceutical, or CRO capacity
* Strong understanding of clinical trial processes and regulatory requirements, including ICH GCP guidelines.
* Demonstrated ability in report writing and strong ability to critically understand clinical research documents
* Excellent organizational and communication skills.
* Ability to work collaboratively in a fast-paced, dynamic environment.
* Demonstrated ability to manage multiple tasks simultaneously and to adapt to changing priorities to meet deadlines
* Proficient with Microsoft Office Suite, Project Management tools. Understanding of clinical trial systems, including EDC, IRT, CTMS, and TMF platforms, is a plus.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Accounting/Auditing, Administrative, and Research
* Industries
Biotechnology Research and Research Services
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