At GenesisCare we want to hear from people who are as passionate as we are about innovation and working together to drive better life outcomes for patients around the world.
Do your life's best work
As the Clinical Research Lead you will be responsible for the management of all aspects of clinical research activities for assigned projects (commercial, collaborative and investigator initiated) 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).
You will work closely with the Clinical Research Manager to improve processes and systems that optimise efficiency. You will ensure that all research is conducted in accordance with GenesisCare SOPs, Good Clinical Practice (GCP) Guidelines and all applicable national and international laws and regulations.
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- 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 for all projects- 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 - Proactively manage all aspects of the trial process including trial timelines, budgets, resources, safety reporting and vendor relationships- Support the PIs and CRCs to engage the doctors and craft groups to ensure study timelines and recruitment targets are met- Collaborate with other functional groups within the company to support milestone achievement and to manage study issues and obstacles- Liaise with and facilitate collaboration between relevant hospital departments and third parties to ensure the provision of quality clinical services- Maintain open and regular communication with key stakeholders, in particular sponsor representatives- Contribute to and ensure all internal policies and systems are followed- Maintain up-to-date knowledge in regulatory, administrative and clinical frameworks and current clinical issues and practice as they pertain to research- Identify quality risks and issues, respond to issues raised by the CRCs, the study team and Quality Team and plan/implement appropriate corrective and preventative action plans- Ensure all research is conducted in accordance with GenesisCare SOPs, Good Clinical Practice (GCP) Guidelines, study specific protocols and all applicable national and international laws and regulations
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 knowledge of Good Clinical Practice and applicable national and international laws and regulation
Who we are:
We are 6000+ highly trained healthcare professionals and support staff across the United States, Australia, the U.K, Spain and China, designing cancer and heart disease treatments to help patients achieve the best possible life outcomes.
Global care
Across the world, we have more than 580+ centres to help us bring the right care to our patients. Every year our team sees more than 1.4 million patients globally across our Oncology, Cardiology & Sleep Medicine Centres.
People centricity is at the heart of what we do and we pride ourselves on making our people a priority, whether that be a patient or an employee. We aim to build culture of 'care' that is patient focused, and performance driven. Our people promise is "do your life's best work, by always growi