Clinical Research Associate II/III - Sydney

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

Benefits offered by this job

Hybrid work arrangements

Flexible working hours

Work-life balance

Job summary

Novotech is seeking a Clinical Research Associate (CRA) to safeguard participant rights and ensure data accuracy. The CRA serves as the primary link between Investigational Sites, Novotech, and Sponsors, ensuring trials comply with ICH GCP and regulatory requirements.

This Sydney-based role offers hybrid working arrangements and flexible hours to support work-life balance. A clinical or life sciences degree is required, with relevant research/pharma experience preferred; full work rights in

Qualifications

• Graduate in a clinical or life sciences-related field.
• Experience in research/pharma or allied fields preferred.
• Must have good time management, attention to detail, and teamwork; able to work remotely/onsite as needed.

Responsibilities

• Build relationships with Principal Investigators, study coordinators, pharmacists, and site trial personnel to ensure efficient trial management.
• Foster internal and external relationships to ensure timely project delivery per study requirements.
• Collaborate with IHCRA and RSA to prepare site essential documents and support ethics/regulatory submissions.
• Understand local and international regulatory requirements for clinical trials with RSU involvement.
• Ensure recruitment of participants and develop site-specific recruitment plans.
• Monitor investigational sites per ICH GCP; conduct visits onsite or remote as CMP allows.

Skills

Attention to detail

Time management

Teamwork

Computer literacy

Education

Bachelor's degree in life sciences or clinical field

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.

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.