Clinical Research Associate - NSW

Novotech; Sydney; On-site; AUD 70,000 - 100,000; Full time

Benefits offered by this job

Flexible working options

Paid parental leave

Flexible leave entitlements

Wellness programs

Ongoing development programs

Job summary

Novotech is seeking a Clinical Research Associate (CRA) to safeguard participant rights and ensure data integrity across trial sites. The CRA serves as the primary contact between Investigational Sites, Novotech and Sponsor, and focuses on building strong site relationships to run trials in accordance with ICH GCP, regulatory requirements, and client SOPs.

Key duties include site monitoring, recruitment support, document preparation with IHCRA and RSA teams, and collaboration to enable timely

Qualifications

• CRA II: minimum 6 months of independent monitoring experience.
• CRA III: 2+ years of independent CRA monitoring experience.
• SCRA: minimum 4 years monitoring, preferably within Oncology.

Responsibilities

• Build relationships with Principal Investigators, study coordinators, pharmacists and site staff to ensure efficient trial management.
• Foster internal and external relationships to support timely and productive project delivery.
• Collaborate with IHCRA and RSA to prepare site essential documents and support ethics/regulatory submissions.
• Understand regulatory requirements with RSU team for applicable trials.
• Drive site recruitment and engagement and prepare recruitment plans.
• Monitor investigational sites across all phases per ICH GCP; visits onsite or remote as CMP permits.

Skills

CRA experience

Oncology monitoring

Regulatory knowledge

Job description

The Clinical Research Associate (CRA), 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 the source documents. The CRA is the primary contact between the Investigational Sites, Novotech and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted 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 CRA independent monitoring experience
• CRA III: 2+ years of CRA independent monitoring experience
• SCRA: min of 4 years monitoring preferable within Oncology

You must have full unrestricted working rights in Australia to be considered for this role

We unfortunately 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 the 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.
• collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start Up Associate (RSA), prepare site essential documents, and support the 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.
• Monitoring of investigational sites as per ICH GCP This includes 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 can be conducted either onsite or remote 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.

• flexible working options
• paid parental leave for both parents
• flexible leave entitlements
• wellness programs
• ongoing development programs

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 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.