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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates advanced site monitoring and clinical trial management skills, with a thorough understanding of regulatory requirements and the drug development process. Proficient in conducting clinical operations activities efficiently while maintaining data confidentiality and ensuring compliance.
Highest-signal resume keywords
Clinical Monitoring ExperienceRegulatory Requirements KnowledgeSerious Adverse Event (SAE) ReportingClinical Trial Management System (CTMS) ExperienceProject Management Experience
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 MonitoringStudy Site ManagementRegistry AdministrationClinical Operations ActivitiesProtocol ComplianceData Integrity ReviewFeasibility WorkBudget NegotiationClinical Research TerminologyMedical Devices Basics
Soft Skills
PlanningOrganizationCommunicationProblem-SolvingTeam Collaboration
Tools & Technologies
Clinical Trial Management System (CTMS)Microsoft Office ApplicationsWindows Operating System
Certifications & Qualifications
Nursing LicensureAllied Health Profession Certification
Industry Keywords
Clinical StudiesDrug Development ProcessInformed Consent ProceduresInvestigator MeetingsEthics Committee SubmissionsRegulatory NotificationsAudit ReadinessClinical Trial Supplies ManagementLocal Project CoordinationMatrix Environment
About the role
Key responsibilities & impact- Perform risk-based monitoring and site management for clinical studies according to sponsor SOPs and regulatory guidelines
- Implement assigned project plans and lead projects of limited scope
- Conduct routine monitoring, close-out, pre-study, and initiation visits at clinical sites
- Maintain study files and liaise with vendors
- Ensure study staff receive appropriate materials and protocol instructions
- Verify informed consent procedures and protocol compliance
- Review source documents and monitor CRF and other data for integrity, missing data, and implausible data
- Ensure site-level audit readiness and manage monitoring tasks efficiently
- Prepare accurate and timely trip reports
- Manage small projects under Project Manager/Director direction
- Serve as lead monitor and assist with monitoring plans and trip report reviews
- Review project progress and initiate actions to meet objectives
- Organize and present at Investigator Meetings
- Participate in protocol, CRF, and clinical trial report development
- Coordinate with internal work groups regarding needs, resources, and timelines
- Manage clinical trial supplies and vendor contacts
- Manage clinical trial registries
- Conduct feasibility work and quality control visits when requested
- Recruit investigators and prepare ethics committee submissions and regulatory notifications
- Coordinate translation of study documentation and organization of meetings
- Negotiate study budgets and assist legal with agreements
- Track and follow up on SAE reporting and produce related reports and narratives
- Perform CRF review, query generation, and query resolution in clinical data management systems
- Assist with training, mentoring, and development of new employees
- Coordinate designated clinical projects as Local Project Coordinator and act as local client contact when assigned
- Travel locally and interstate for site monitoring visits
Requirements
What you’ll need- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure), or equivalent experience
- Minimum of 6 years recent clinical monitoring experience may substitute for the education requirement
- Thorough knowledge of regulatory requirements
- Thorough understanding of the drug development process
- Fluent in the local office language and English, written and verbal
- Full understanding of Serious Adverse Event (SAE) reporting, report production, narratives, and SAE follow-up
- Advanced site monitoring, study site management, and registry administration skills
- Ability to work with minimal supervision
- Good planning, organization, and computer skills
- Advanced verbal and written communication skills
- Ability to train and supervise junior staff
- Ability to resolve project-related problems and prioritize workload for self and team
- Ability to work within a project team and effectively in a matrix environment
- Local project coordination and/or project management experience preferred
- Ability to maintain confidentiality of data and information
- Demonstrated ability to conduct clinical operations activities efficiently
- Strong understanding of medical and clinical research terminology and processes
- Understanding of physiology, pharmacology, and medical devices basics when applicable
- Strong understanding of Australian regulatory requirements
- Working knowledge of PCs, Windows, and Microsoft Office applications
- Experience using a clinical trial management system (CTMS)
Benefits
Comp & perks- Hybrid work arrangement
- Full-time employment
- Travel expenses managed according to Fortrea travel policy
- EEO and accommodations support