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Clinical Research LeadGenesisCare
Do your life's best work We are looking for 2 x Clinical Research Lead (Medical Oncology or Theranostics) to join our fast-growing medical oncology research team . As the Clinical Research Lead, you will be responsible for the management of all aspects of clinical research activities (commercial, collaborative and investigator initiated) for assigned projects and for meeting key project metrics, particularly regarding quality, timelines and recruitment. You will work in a matrix environment and support the Principal Investigators (PI's) and Co-Investigator's together with the site Clinical Research Coordinators (CRC) and Research Assistants (RA).
The roles can be Sydney or Perth based. What you'll do: Have a thorough understanding of all trials being conducted, particularly the protocol, investigator brochure, participant information and consent forms, budget, timelines and safety reporting requirements Work with the Clinical Research Manager to ensure the research governance framework and processes are fully implemented in responsible areas, including, but not limited to, research approval, activation and ongoing safety reporting Assist the Clinical Research Manager with feasibilities and the Start Up team with study start up activities including vendor selection and completion of regulatory documentation Proactively manage all aspects of the trial process including trial timelines, budgets, resources, safety reporting and vendor relationships Assist the Investigators and Research Team with protocol and PICF development for Investigator-Initiated projects Assist with the development and review of project plans and required study documents Develop, implement and manage pre-screening and recruitment plans and tools in consultation with the CRC's Work with CRCs to ensure recruitment plans are in place and reviewed on a regular basis Arrange and attend Pre-Selection/Site Qualification Visits and Site Initiation Visits, as required Provide protocol specific training, expert advice and high-level support to CRC's and RA's Coordinate and review monitoring reports to ensure protocol adherence Support the PIs and CRCs to engage the doctors and craft groups to ensure study timelines and recruitment targets are met Participate in trial working groups/committees Who you are: An undergraduate degree deemed equivalent in Science, Nursing, Pharmacy or related discipline At least 5 years' experience in clinical research Experience across a range of oncology trials Proven track records of research project management or demonstrated ability to lead a project Ability to work in a matrix environment Excellent communication and interpersonal skills with the ability to work both independently and as part of a team in an effective, proactive and co-operative manner High level of initiative and flexibility and the ability to meet deadlines while balancing multiple priorities Strong computer literacy with knowledge of clinical trials software and MS Office suite Expert....