Sr Clinical Research Monitor (CRA)

Junee Southern Cross; Melbourne; Hybrid; AUD 100,000 - 130,000; Full time

Benefits offered by this job

Flexible Benefits

Competitive Pay & Benefits Package

Job summary

Medtronic in Melbourne, Australia, is seeking a Senior Clinical Research Monitor (CRA) to oversee clinical trial execution at assigned sites from start-up to closeout. The role requires extensive site monitoring experience, strong partnerships with investigators, and ensuring compliance with GCP and regulatory requirements.

Travel to research sites across a diverse portfolio is expected. The successful candidate will manage multiple studies, support start-up activities, and mentor junior CRAs,

Qualifications

• Requires a Bachelor degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
• Experience conducting on-site and remote monitoring visits across multiple clinical studies.
• Experience in Good Clinical Practice (GCP), ICH guidelines, and clinical research regulations.
• Experience with CTMS, EDC, and Microsoft Office applications.
• Experience managing investigator relationships, site performance, and clinical trial execution.

Responsibilities

• Lead site monitoring activities throughout the study lifecycle, including site qualification, initiation, interim monitoring, and closeout visits.
• Serve as primary sponsor contact for assigned sites and maintain relationships with investigators, study coordinators, hospitals, and research institutions.
• Ensure studies are conducted, documented, and reported in compliance with protocols, GCP, regulatory requirements, and Medtronic procedures.
• Review source documentation, study data, deviations, adverse events, and site performance to ensure patient safety and data integrity.
• Support site start-up activities, including feasibility assessments, ethics submissions, investigator documentation, and site activation.
• Train investigators and site personnel on protocol requirements, investigational devices, and compliance expectations.
• Drive patient recruitment, retention, and study execution through proactive site management and performance oversight.
• Contribute to clinical development initiatives, process improvements, study planning, and cross-functional projects.

Skills

Site Monitoring

GCP/ICH

Stakeholder Mgmt

CTMS/EDC

MS Office

Education

Bachelor degree

Advanced degree

Tools

CTMS

EDC

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

The Clinical Research and Medical Science function generates and translates clinical evidence to support the safe and effective use of Medtronic therapies throughout the product lifecycle. This team partners with investigators, healthcare institutions, and cross-functional stakeholders to execute clinical studies that advance patient care and support regulatory, scientific, and business objectives. The team oversees the full spectrum of clinical trial activities, from site identification and start-up through study closeout, while ensuring compliance with Good Clinical Practice (GCP), regulatory requirements, and Medtronic standard operating procedures. This role provides the opportunity to work across multiple therapy areas and medical device technologies while contributing to a growing global clinical research portfolio.

This position is based in Melbourne, Australia and operates in an onsite work environment. Some travel is required to support site monitoring activities, investigator engagement, and clinical study execution across assigned research sites.

As a Senior Clinical Research Monitor (CRA), you will serve as the sponsor representative responsible for overseeing clinical trial execution at assigned investigational sites from start-up through study closeout. You will independently manage site monitoring activities, build strong partnerships with investigators and site personnel, and ensure studies are conducted in accordance with study protocols, Good Clinical Practice (GCP), regulatory requirements, and Medtronic procedures. This role requires extensive site monitoring experience and the ability to manage multiple studies across a diverse portfolio of medical device clinical trials.

Primary Responsibilities:

• Lead site monitoring activities throughout the study lifecycle, including site qualification, site initiation, interim monitoring, and closeout visits.
• Serve as the primary sponsor contact for assigned sites and maintain effective relationships with investigators, study coordinators, hospitals, and research institutions.
• Ensure clinical studies are conducted, documented, and reported in compliance with study protocols, Good Clinical Practice (GCP), regulatory requirements, and Medtronic standard operating procedures.
• Review source documentation, study data, protocol deviations, adverse events, and site performance to ensure patient safety and data integrity.
• Support site start-up activities, including feasibility assessments, ethics submissions, investigator documentation, and site activation requirements.
• Train investigators and site personnel on protocol requirements, investigational devices, study procedures, and compliance expectations.
• Drive patient recruitment, retention, and study execution through proactive site management and performance oversight.
• Contribute to clinical development initiatives, process improvement activities, study planning, and cross-functional project teams.

Required Qualifications

• Requires a Bachelor degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
• Experience conducting on-site and remote monitoring visits across multiple clinical studies.
• Experience in Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and clinical research regulations.
• Experience with Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and Microsoft Office applications.
• Experience managing investigator relationships, site performance, and clinical trial execution across the study lifecycle.

Preferred Qualifications

• 5 years of clinical monitoring experiences
• Experience monitoring medical device clinical trials.
• Experience supporting site feasibility, ethics submissions, site activation, and study start-up activities.
• Experience reviewing adverse events, protocol deviations, and risk-based monitoring metrics.
• Experience mentoring Clinical Research Associates (CRAs) or supporting study team development.
• Knowledge of Australian and global clinical research regulations and requirements.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

• Medtronic offers a competitive Salary and flexible Benefits Package
• A commitment to our employees lives at the core of our values.
• We recognize their contributions.
• They share in the success they help to create.
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).