Clinical Research Associate II/III - NSW

Novotech Global; Sydney; Hybrid; AUD 80,000 - 110,000; Full time

Job summary

Novotech in Sydney seeks a Clinical Research Associate II/III to ensure participant safety, data integrity, and accurate source documentation. You will act as primary site liaison between investigators, Novotech, and Sponsors, ensuring trials comply with ICH GCP and regulatory requirements.

The role is based in Sydney with hybrid working arrangements and flexible hours to support work-life balance in a dynamic clinical environment.

Qualifications

• Graduate in a clinical or life sciences-related field.
• Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate.

Responsibilities

• Build relationships with Principal Investigators, study coordinators, pharmacists, and site trial personnel to ensure efficient management of clinical trials.
• Foster internal and external customer relationships to ensure focused, 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/approval processes as needed.
• With RSU, understand requirements of applicable local and international regulatory requirements for specific trials.
• Ensure recruitment of participants as per site target; drive site recruitment and engagement plans.
• Monitor investigational sites across all phases of a clinical trial, including Site Selection, Site Initiation, Site Monitoring, and Site Close Out; visits can be onsite or remote as per CMP.

Skills

Time management

Attention to detail

Team player

Computer literacy

Education

Bachelor’s degree in clinical or life sciences

Job description

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Basic info

• Requisition Status Open - Posted
• Requisition Type Standard
• Requisition Number 4490
• Requisition Title Clinical Research Associate II/III - Sydney
• Number of Openings 1
• Requisition Template

Hiring team

• Hiring Manager Daniela Caiazza Vice President Clinical Services ANZ
• Recruiter Pat Ng Senior Talent Acquisition Specialist
• Collaborator Passant Zaki Director Clinical Operations Actions
• Collaborator Priyanka Sharma Senior Talent Acquisition Specialist Actions
• Collaborator Kaye Sambells Senior Clinical Operations Manager Actions

Business Justification

Replacement Languages American English (Default)

Requisition structure

Recruiting Type Non Executive Level 1

Organization Novotech (Australia) Pty Ltd, Novotech Health Holdings

Job Family

Job Function

Work Preferences

• Travel Required
• International Travel Required
• Willing to Relocate
• Work Duration Months

Details

• Worker Type Employee
• Regular or Temporary Regular
• Full Time or Part Time Full time
• Education Level Employee being replaced: Luke Adair Requisition Cancel Reason

Posting 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.

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.