(Senior) Clinical Research Associate

IQVIA; Melbourne; Hybrid; AUD 105,000 - 145,000; Full time

Benefits offered by this job

Car allowance

Health allowance

Job summary

IQVIA is seeking a Clinical Research Associate to monitor and manage study sites across multiple Australian trials. You will ensure adherence to protocol, GCP, and regulatory requirements while coordinating with site staff to drive data quality and timely reporting.

The role requires on-site visits, clear communication, and strong organizational skills. A hybrid setup with a Melbourne office supports career growth within our global CRO network.

Qualifications

• Bachelor's degree in scientific discipline or health care
• At least 9 months of independent on-site monitoring experience
• Equivalent combination of education, training and experience may be accepted
• Good knowledge of GCP and ICH guidelines
• Proficient in Word, Excel and PowerPoint; able to use mobile devices as applicable

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and regulatory requirements (GCP/ICH)
• Drive subject recruitment plans with sites to enhance predictability
• Administer protocol training to sites and maintain regular communication
• Evaluate site practices for protocol and regulatory compliance; escalate issues
• Track regulatory submissions, recruitment, CRF completion, data query resolution; may support start-up
• Maintain site documents and TMF/ISF in compliance with GCP/regulations
• Collaborate with study team for project execution
• Support development of project recruitment plans per site
• Manage site financials per trial agreement and invoice retrieval as required

Skills

On-site monitoring

Regulatory knowledge

Communication

Organizational skills

Problem solving

Education

Bachelor's degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Laptop

iPhone/iPad

Job description

Are you aClinical Research Associatelooking 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.

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.

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.

Candidates will be assessed according to their years of experience and be considered for various levels where applicable.

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

CRA 2: Base AUD$105,000 + Car AUD18,000 + Super

SCRA3: Base AUD$125,000 + Car AUD$20,000 + Super