About the Role
We are seeking an experienced Senior Clinical Research Associate (Senior CRA) to join our Early Phase team based in Melbourne, Australia. This is a unique opportunity to play a foundational role in establishing Early Phase monitoring capability, contributing to operational frameworks, and supporting the growth of early phase clinical research activities in Australia. The successful candidate will lead monitoring activities across first‐in‐human, Phase I, Ib, and early Phase II studies, while also helping shape best practices, processes, and ways of working for the Early Phase team.
Responsibilities
* Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial.
* Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe.
* Prepare, plan, organise, and conduct site evaluation visits and report on these visits to assist with site selection.
* Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages.
* Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments.
* Prepare, plan, organise, and conduct site initiation visits.
* Develop and maintain appropriate monitoring tools and project-specific documents.
* Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines.
* Manage trial sites utilising both on-site and off-site activities.
* Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing.
* Reconcile contents of in-house TMF and site's Investigator Site Files.
* Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements.
* Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial.
* Support strategies to boost recruitment efforts.
* Coordinate and perform translation verification of regional language, as required or as applicable per region.
* Perform site close-out visits and other site activities including archiving, as applicable.
* Mentor, coach, and train junior staff members as directed by line management.
* Perform any additional responsibilities assigned by the Line Manager and/or Project Lead.
About You
* Educated to degree level in pharmacy, medical, nursing, biological science, or other health‐related disciplines preferred.
* Must have at least 5 years on‐site monitoring experience in Australia as a CRA.
* Experience with Oncology and Early Phase trials is highly regarded.
* Displays high competence in ethical and participant safety considerations, site start‐up management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.
* Demonstrates high competence in negotiation and conflict resolution, critical thinking, problem‐solving, decision making, and strategic thinking.
* Demonstrates solid interpersonal communication skills, presentation skills, is flexible, and can work well within a multi‐disciplinary team both autonomously and with a wide range of varying stakeholders.
We are an equal‐opportunity employer and encourage applications from all qualified candidates.
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