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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Monitoring and adherence to regulatory requirements, ensuring data integrity and participant safety in clinical trials. Proficient in managing study sites, conducting monitoring visits, and training staff within a fast-paced, technology-driven environment.
Highest-signal resume keywords
Clinical Monitoring ExperiencePhase I ExperienceNursing LicensureData Integrity ManagementSerious Adverse Event Reporting
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementData Collection ToolsCase Report Form ReviewFeasibility AssessmentEmergency Response Procedures
Soft Skills
Teamwork OrientationAdaptability to ChangeEffective Communication
Tools & Technologies
FortreaData Management Systems
Certifications & Qualifications
University or College DegreeCertification in Allied Health Profession
Industry Keywords
Clinical Research StandardsInformed Consent ProceduresStudy Site ManagementMonitoring Data IntegrityLocal Project Coordinator
About the role
Key responsibilities & impact- Provide a high standard of care for participants in clinical trials
- Respond to emergency situations according to clinical research standards
- Conduct routine monitoring and close-out of clinical sites
- Maintain study files
- Conduct pre-study and initiation visits
- Liaise with vendors
- Manage study sites according to project plans
- Ensure study staff receive proper materials and instructions to safely enter patients into the study
- Verify informed consent procedures and protocol requirements comply with applicable regulatory requirements
- Ensure data integrity in Case Report Forms and other data collection tools
- Monitor data for missing or implausible data
- Manage study registries and undertake feasibility work when requested
- Complete Serious Adverse Event reporting, narratives, reports, and follow-up
- Perform CRF review and query generation and resolution using Fortrea or client data management systems
- Assist with training new employees through co-monitoring
- Coordinate designated clinical projects as a Local Project Coordinator, with supervision where applicable
- Act as a local client contact when assigned
- Perform other duties as assigned by management
- Travel frequently to client and site locations, including occasional domestic and international travel
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)
- 1+ years of Clinical Monitoring experience
- Phase I experience
- Ability to undertake 40-50% overnight travel
- Comfort working in a fast-paced, changing-priority, teamwork-oriented, technology-based environment
- Ability to sit for extended periods and operate a vehicle safely
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
- Occasional crouching and stooping, with frequent bending and twisting of the upper body and neck
- Ability to access and use a variety of in-house and off-the-shelf computer software
- Ability to lift and carry objects, luggage, and a laptop computer weighing up to 15-20 lbs
- Regular and consistent attendance
- Varied hours may be required
Benefits
Comp & perks- Remote work arrangement
- 40-50% overnight travel
- Ongoing application acceptance
