Overview
The Clinical Research Associate (CRA II – 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 source documents. The CRA acts as the primary contact between investigational sites, Novotech, and Sponsor. Key responsibilities include site relationship management to ensure trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.
Working arrangements
We offer hybrid working arrangements and full flexibility in working hours to support a healthy work-life balance.
Qualifications
* Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered.
* Good time management, attention to detail, ability to work well in a team, and computer literacy.
* Experience by job level: CRA II – minimum 6 months of independent CRA monitoring experience; CRA III – 2+ years; SCRA – minimum 4 years of CRA monitoring experience.
You must have full unrestricted working rights in Australia to be considered for this role based in QLD. We cannot provide sponsorship for this role.
Responsibilities
* Build relationships with Principal Investigators, study coordinators, pharmacists, and site trial personnel to ensure efficient, expedited, and smooth management of clinical trials.
* Foster internal and external customer relationships to support efficient, timely, and productive project delivery as per study requirements and timelines.
* Collaborate with IHCRA and RSA, prepare site essential documents, and support ethics and regulatory submission and approval processes as needed.
* In collaboration with the RSU team, understand the requirements of applicable local and international regulatory requirements relevant to specific clinical trials.
* Ensure recruitment of participants as per site targets; drive site recruitment and engagement initiatives and prepare site-specific recruitment plans.
* Monitor investigational sites per ICH GCP across all phases of a clinical trial, including Site Selection, Site Initiation, Site Monitoring, and Site Close-Out, as well as unblinded pharmacy visits and co-monitoring visits. Visits may be onsite or remote as per CMP.
About Novotech & Equal Opportunity
Novotech is committed to gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. We support flexible working options, parental leave for both parents, flexible leave entitlements, wellness programs, and ongoing development opportunities. We encourage applicants who identify as LGBTIQ+, have a disability, or have caring responsibilities. We are a Circle Back Initiative Employer and will respond to every application.
Position details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Research and Science
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