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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading clinical site monitoring activities, ensuring compliance with GCP and regulatory requirements, and managing investigator relationships throughout the study lifecycle. Proficient in clinical trial execution, site start-up processes, and mentoring team members to enhance study performance.
Highest-signal resume keywords
Clinical Site MonitoringGood Clinical Practice (GCP)Clinical Trial Management Systems (CTMS)Electronic Data Capture (EDC)Investigator Relationship Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site QualificationSite InitiationInterim MonitoringCloseout VisitsProtocol Deviation ReviewAdverse Event ReviewRisk-Based MonitoringFeasibility AssessmentsStudy Data ReviewPatient Recruitment
Soft Skills
Relationship ManagementTraining and MentoringCross-Functional CollaborationCommunication
Tools & Technologies
Microsoft Office Applications
Industry Keywords
Clinical Research RegulationsInternational Council for Harmonisation (ICH)Medical Device Clinical TrialsStudy Protocol ComplianceSite Activation Requirements
About the role
Key responsibilities & impact- 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 relationships with investigators, study coordinators, hospitals, and research institutions
- Ensure clinical studies are conducted, documented, and reported in compliance with study protocols, GCP, regulatory requirements, and Medtronic 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
- Travel to assigned research sites for monitoring activities, investigator engagement, and clinical study execution
Requirements
What you’ll need- 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
- 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
Comp & perks- Flexible Benefits Package
- Competitive compensation plans
- Short-term incentive through the Medtronic Incentive Plan (MIP)
- Flexible Work Arrangement