Senior / Clinical Research Associate

IQVIA; New South Wales; On-site; AUD 85,000 - 110,000; Full time

Job summary

IQVIA LLC is seeking an on-site Clinical Research Monitor to ensure sites conduct studies and report data per protocol, GCP, ICH, and sponsor requirements.

You’ll manage monitoring visits, training, site communication, and data quality, with the potential to support start-up activities and TMF/ISF maintenance. Strong regulatory knowledge and Excel/Word skills are essential.

Qualifications

• Bachelor's Degree in scientific discipline or health care.
• 1 year of on-site monitoring experience required.
• Equivalents accepted in lieu of degree.
• GCP/ICH regulatory knowledge.
• Good English written and verbal communication.
• Proficient Microsoft Word, Excel, and PowerPoint.
• Organizational, time management and problem-solving abilities.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope.
• Collaborate with sites to support recruitment plans and project needs.
• Administer protocol training and maintain site communications.
• Evaluate site practices for protocol compliance and regulatory adherence.
• Escalate quality issues as appropriate.
• Track regulatory submissions, recruitment, CRF completion, and data queries.
• Support start-up phase as applicable.
• Maintain TMF and ISF documentation and filings.
• Generate visit reports and follow-up letters.
• Coordinate with study team for project execution and site finances as needed.

Skills

English communication

Organizational skills

Problem-solving

Time management

Relationship building

Team collaboration

Education

Bachelor’s degree in scientific discipline or health care

Tools

MS Word

Excel

PowerPoint

Laptop

iPhone/iPad

Job description

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 1 year of 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).
• Written and verbal communication skills including good command of English language.
• 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.

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.