18 Oct
|
Alignerr
|
Melbourne
18 Oct
Alignerr
Melbourne
Senior Clinical Research Monitor (CRA)
Location: Melbourne, Australia – onsite
Contract type: Full time
Travel: Yes, 10% of the Time
Clearance Type: AU-Secret (NV1)
Relocation Assistance: No relocation assistance available
AUSTRALIAN CITIZENSHIP REQUIRED FOR THIS POSITION: Yes
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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Advantages 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).
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
Equal Employment Opportunity
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E‑Verify program, please click here ( .
We are an equal opportunity employer. We extend equal opportunity to all individuals without regard to an individual's race, religion, color, national origin, ancestry, sex, sexual orientation, gender identity, age, physical or mental disability, medical condition, genetic characteristics, veteran or marital status, pregnancy, or any other classification protected by applicable local, state or federal laws. We are committed to the principles of fair employment and the elimination of all discriminatory practices.
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