Dynamic Classroom Teacher: Evidence-Based Instruction

Department Of Education Victoria; City of Melbourne; Hybrid; AUD 85,000 - 110,000; Full time

Benefits offered by this job

Flexible hybrid work

Car and health allowances

Career growth

Work with skilled managers

Job summary

IQVIA is seeking a Clinical Research Associate in Australia to perform monitoring and site management across studies, ensuring compliance with GCP/ICH and sponsor requirements. You will support site qualification, recruitment tracking, and data integrity while maintaining thorough documentation.

The role offers a flexible hybrid workplace with offices in Melbourne and Sydney, with competitive salary and benefits.

Qualifications

• Bachelor's degree in a scientific field or healthcare.
• At least 9 months of independent on-site monitoring experience.
• Knowledge of GCP/ICH guidelines and regulatory requirements.
• Understanding of protocol/trial conduct and data handling.
• Proficiency with MS Office and basic device usage.

Responsibilities

• Perform site monitoring visits per scope and regulatory requirements.
• Collaborate with sites to manage recruitment and study progress.
• Administer protocol training and maintain communication with sites.
• Evaluate site practices for quality and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion, and data queries.
• Maintain TMF/ISF documentation and file management.
• Prepare visit reports and communicate findings to the study team.
• Support cross-site project execution and coordination.

Skills

Site monitoring

Regulatory knowledge

Communication

Documentation

Study coordination

Problem-solving

Team collaboration

Education

Bachelor's Degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Laptop

iPhone/iPad

Job description

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Melbourne, Australia
North Sydney, New South Wales, Australia
Full time
R
Are you a Clinical Research Associate looking for your next big adventure?

Look no further than IQVIA, a global CRO with outstanding reputation.

Our CRA teams have current openings across various locations in Australia.

*Visa sponsorship for candidates that meet the requirements and eligibility. Only suitable candidates will be contacted.

The role:

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

Qualifications

• Bachelor's Degree in scientific discipline or health care.
• Requires at least 9 months of independent on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
• Organizational and problem-solving skills.
• Effective time and financial management skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

What’s in it for you?

• Flexible hybrid work environment, with an office in the heart of Melbourne and Sydney.
• Competitive salary with car and health allowances.
• Career growth and opportunity across our FSO and FSP models.
• Work with skilled Managers across multi-phases clinical trials

If you are interested and meet the skills and experience above, please apply with your resume today.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

EEO Minorities/Females/Protected Veterans/Disabled

Sydney North, New South Wales, Australia
Melbourne, Australia
Full time
R
Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.