Clinical Research Associate Fsp
Vor 5 Tagen
Join Novotech in this newly created single sponsor (FSP) CRA role and align your previous CRA experience with one of the fastest growing APAC CROs.
This role will be based in Melbourne or Sydney with travel to New Zealand.
Acting as the primary link between a single sponsor, you will be responsible for: Acting as a site manager to ensure that clinical trials are conducted and documented as per ICH GCP guidelines, global and local regulatory requirements and Novotech/Client SOPs; Providing mentorship to less experienced staff; Providing support to the project manager as required; and Performing site selection visits to ensure sites have adequate resources to conduct studies.
Minimum Qualifications & Experience: Min of 2 years of independent clinical monitoring experience and experience on EC submission and CRA amendment.
Willing to travel to NZ Tertiary qualifications in clinical or life sciences related field (relevant experience/qualifications in similar professions may also be considered); Solid knowledge of GCP, national and international regulations and a sound understanding of how they apply to you; Excellent interpersonal and team skills with a genuine commitment to contributing to the development of innovative treatments; Previous experience in monitoring oncology trials would be highly desirable; and A strong track record of performing visits to sites according to the Clinical Monitoring Plan.
Novotech is proud to offer a great workplace.
We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what we do, but we understand work is only one of the things that is important to them.
We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs.
We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities.
We are a Circle Back Initiative Employer and commit to respond to every application.
We look forward to contacting you regarding your application.
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