Join to apply for the
Clinical Research Associate - VIC
role at
Novotech
.
The Clinical Research Associate (CRAII – SCRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and that reported trial data are accurate, complete, and verifiable from the source documents. The CRA serves as the main point of contact between the Investigational Sites, Novotech, and the Sponsor, and manages the site relationship to conduct clinical trials in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.
Minimum Qualifications & Experience
CRA II:
minimum of 6 months of independent CRA monitoring experience
CRA III:
2+ years of independent CRA monitoring experience
SCRA:
minimum of 4 years of independent monitoring experience
You must have full unrestricted working rights in Australia to be considered for this role.
We cannot provide sponsorship.
Responsibilities
Build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure efficient, timely and smooth management of clinical trials.
Foster internal and external customer relationships to focus on efficient, timely and productive project delivery as per study requirements and timelines.
Collaborate with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA) to prepare site essential documents and support ethics and regulatory submissions and approvals as needed.
In partnership with the Regulatory Start-up (RSU) Team, understand applicable local and international regulatory requirements relevant to specific clinical trials.
Ensure recruitment of participants per site target, drive site recruitment and engagement initiatives, and prepare site-specific recruitment plans.
Monitor investigational sites as per ICH GCP, covering all monitoring visit types across all phases of a clinical trial, including Site Selection, Site Initiation, Site Monitoring, and Site Close-Out, unblinded pharmacy visits, and co-monitoring visits. Visits may be conducted onsite or remotely as per CMP.
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. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development opportunities. We welcome applicants who identify as LGBTIQ+, have a disability, or have caring responsibilities.
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