Overview
Clinical Research Associate (CRAII - SCRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from source documents. The CRA is the primary contact between Investigational Sites, Novotech and Sponsor. A key responsibility of a CRA is to be a site relationship manager to ensure trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.
We offer hybrid working arrangements and full flexibility in working hours to help staff achieve work-life balance.
Minimum Qualifications & Experience
General requirements: Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. For current opportunities, experience in the research or pharmaceutical industry or a related field is required as per job level:
* CRA II: minimum of 6 months of CRA independent monitoring experience
* CRA III: 2+ years of CRA independent monitoring experience
* SCRA: minimum of 4 years CRA monitoring experience
You must have full unrestricted working rights in Australia to be considered for this role. We cannot provide sponsorship for this role.
Responsibilities
* CRAs primary responsibility is to build relationships with Principal Investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure an efficient, expedited, and smooth management of clinical trials.
* Foster internal and external customer relationships to ensure 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), prepare site essential documents, and support ethics and regulatory submission and approval processes as needed.
* In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials.
* Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required.
* Monitor investigational sites as per ICH GCP including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted onsite or remote as per CMP.
Other details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Research and Science
Novotech is an inclusive employer and supports flexible working options, parental leave, flexible leave entitlements, wellness programs and ongoing development. We are an equal opportunity employer and welcome applicants from diverse backgrounds, including those 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.
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