Clinical Research Associate

IQVIA; Melbourne; On-site; AUD 85,000 - 110,000; Full time

Benefits offered by this job

Flexible hybrid work environment

Salary with health allowances

Job summary

IQVIA in Australia is seeking a Clinical Research Associate to monitor sites and manage study data per GCP/ICH guidelines. The role covers on-site visits, site management, and collaboration with study teams across Melbourne.

Applicants should have a degree in a scientific field and at least 9 months on-site monitoring experience, plus MS Word/Excel/PowerPoint skills. IQVIA offers visa sponsorship where eligible and a flexible hybrid work setup.

Qualifications

• Bachelor's degree in scientific discipline or health care.
• At least 9 months of independent on-site monitoring experience.
• Good knowledge of GCP and ICH guidelines.
• Proficiency with MS Word, Excel and PowerPoint.

Responsibilities

• Perform site monitoring visits (initiation, monitoring, close-out) per GCP/ICH and contract scope.
• Coordinate recruitment plans to meet project needs.
• Administer protocol training to sites and maintain regular communication.
• Evaluate site practices for protocol compliance and data quality.
• Manage progress of studies by tracking submissions, enrollment, CRFs and data queries.

Skills

Site monitoring

GCP/ICH knowledge

MS Word

MS Excel

PowerPoint

Education

Bachelor's degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft 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.

*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.
• 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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.