Clinical Research Associate II/III - NSW

Novotech; Sydney; Hybrid; AUD 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid work arrangements

Flexible working hours

Job summary

Novotech is seeking a Clinical Research Associate (CRA) to safeguard trial participant welfare and ensure accurate, verifiable data across source documents. The CRA acts as the primary contact between Investigational Sites, Novotech and Sponsor, maintaining site relationships and coordinating regulatory compliance.

The Sydney-based role offers hybrid work arrangements and flexible hours to support work-life balance while delivering high-quality clinical trial monitoring and site management

Qualifications

• Graduate in a clinical or life sciences-related field.
• Experience in research/pharmaceutical industry or related field per job level.
• Must have full unrestricted working rights in Australia; sponsorship not provided.

Responsibilities

• Build relationships with Principal Investigators, study coordinators, pharmacists and trial personnel to ensure efficient trial management.
• Foster internal and external stakeholder relationships to support timely project delivery.
• Collaborate with IHCRA and RSA to prepare site essential documents and support ethics/regulatory submissions.
• Understand local and international regulatory requirements related to clinical trials.
• Oversee site recruitment and engagement, and develop site-specific recruitment plans.
• Monitor investigational sites across all phases, on-site or remote as required.

Skills

Site relationship management

Time management

Attention to detail

Computer literate

Education

Bachelor's degree in clinical or life sciences

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.

This role will be based in Sydney and we offer hybrid working arrangements and full flexibility in working hours to ensure our staff achieve the work-life balance often missing in this role.

Minimum Qualifications & Experience

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 our current opportunities we require experience of working in the research, pharmaceutical industry or a related field per job level as follows:

• CRA II: minimum of 6 months of CRA independent monitoring experience
• CRA III: 2+ years of CRA independent monitoring experience

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.