Clinical Research Associate

IQVIA; Sydney; Hybrid; AUD 70,000 - 100,000; Full time

Benefits offered by this job

Flexible hybrid work environment

Car and health allowances

Job summary

IQVIA in Australia seeks a Clinical Research Associate to perform site monitoring and site management to ensure studies comply with protocol, GCP/ICH, and sponsor requirements. You will support site activities across Melbourne and Sydney, operating in a hybrid work environment with regular site visits.

The role emphasizes training, communication with sites, data integrity, and regulatory tracking, with opportunities to advance across trials and locations within IQVIA's global CRO network.

Qualifications

• Requires a Bachelor's Degree in a scientific discipline or healthcare.
• Requires at least 9 months of independent on-site monitoring experience.
• Knowledge of GCP/ICH guidelines and regulatory requirements.
• Proficient in MS Word, Excel and PowerPoint.
• Strong organizational and time management skills.
• Ability to build effective working relationships with teams.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and GCP/ICH guidelines.
• Drive subject recruitment plans aligned with project needs to enhance predictability.
• Administer protocol training to sites and maintain regular communication with site staff.
• Evaluate site practices for protocol adherence and regulatory compliance; escalate issues.
• Track regulatory submissions, approvals, recruitment, CRF completion and data queries; support start-up if needed.
• Maintain Trial Master File (TMF) and Investigator's Site File (ISF) as required by regulations.
• Document site management activities and generate visit reports and follow-up letters.

Skills

On-site monitoring

GCP/ICH knowledge

Site management

Communication

Problem solving

Education

Bachelor's Degree in scientific discipline

Tools

Microsoft Word

Excel

PowerPoint

Job description

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.

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.
• 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

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 https://jobs.iqvia.com

IQVIA 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.