Clinical Research Associate (Level I/II)

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Clinical Research Associate (Level I/II) - Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level I/ II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.

What You'll Do:

• Conducts risk-based site monitoring (on-site and remote), ensuring protocol compliance, data accuracy (SDR/SDV/CRF), and investigational product accountability; identifies issues using root cause analysis and drives corrective/preventive actions through to resolution.
• Manages site lifecycle activities including feasibility, initiation, routine monitoring, and close-out, ensuring adherence to ICH-GCP, regulatory requirements, and study protocols.
• Maintains complete and accurate trial documentation and systems (e.g. CTMS), provides status updates to the clinical team, and supports investigator payments where required.
• Acts as the key liaison between sites, sponsor, and project team; escalates and resolves issues, supports audits/inspections, and ensures ongoing site communication and performance.
• Contributes to team deliverables and continuous improvement initiatives, while completing administrative tasks in a timely manner.

Education and Experience Requirements:

• Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship.
• Valid Australian driver's license
• Australian Citizenship or Permanent Resident required

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Proven clinical monitoring skills