Senior Clinical Research Associate - NSW

Novotech; Sydney; Hybrid; AUD 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work

Flexible hours

Job summary

Novotech in Sydney is seeking a Senior Clinical Research Associate (SCRA) to ensure rights and wellbeing of trial participants and accuracy of trial data. You will act as the primary contact between Investigational Sites, Novotech and Sponsor, ensuring trials meet ICH GCP and regulatory standards.

This role is based in Sydney with hybrid working arrangements and flexible hours to support work-life balance. Applicants must have unrestricted working rights in Australia and experience in clinical

Qualifications

• Graduate in a clinical or life sciences-related field.
• 3+ years of CRA independent monitoring experience, preferably within Oncology.
• Full unrestricted working rights in Australia; sponsorship is not available.

Responsibilities

• Build relationships with investigators, study coordinators, pharmacists, and site trial personnel.
• Foster relationships to ensure timely and productive project delivery.
• Collaborate with IHCRA and RSA to prepare essential site documents.
• Support ethics and regulatory submission and approval processes.
• Understand local and international regulatory requirements relevant to trials.
• Drive site recruitment and engagement plans and monitor trials per ICH GCP.

Skills

Time management

Attention to detail

Team player

Education

Graduate in clinical or life sciences-related field

Job description

Senior Clinical Research Associate - NSW

The Senior Clinical Research Associate (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 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:

• SCRA: minimum of 3 years of CRA independent monitoring experience, preferably 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.