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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 management of clinical trials, ensuring compliance with protocols and regulatory standards. Proficient in data management, including CRF review and SAE reporting, while effectively coordinating with study sites and vendors.
Highest-signal resume keywords
Clinical Monitoring ExperiencePhase I ExperienceNursing LicensureData Management SystemsEmergency Response
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 ManagementCRF ReviewSAE ReportingSource-Document MonitoringProtocol ComplianceFeasibility WorkData VerificationMonitoring Study SitesEmergency Situations ResponseTraining New Employees
Soft Skills
Teamwork OrientationAdaptabilityCommunication SkillsAttention to DetailProblem-Solving
Tools & Technologies
FortreaClient Data-Management SystemsComputer Software
Certifications & Qualifications
University or College DegreeCertification in Allied Health Profession
Industry Keywords
Clinical TrialsInformed Consent ProceduresClinical Research StandardsStudy Files ManagementProject Plans
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
- Monitor clinical study sites, including routine monitoring and close-out visits
- Maintain study files and conduct pre-study and initiation visits
- Liaise with vendors
- Manage sites according to project plans
- Ensure study staff receive proper materials and instructions
- Verify informed consent procedures and protocol compliance
- Ensure integrity of CRF and other data through source-document monitoring
- Monitor data for missing or implausible information
- Manage clinical registries and undertake feasibility work
- Complete SAE reporting, narratives, reports, and follow-up
- Perform CRF review and generate and resolve queries in Fortrea or client data-management systems
- Assist with training new employees through co-monitoring
- Coordinate designated clinical projects as a Local Project Coordinator
- Act as a local client contact when assigned
- Perform other duties assigned by management
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
- Ability to work 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 ability to make fast, simple, repeated movements of fingers, hands, and wrists
- Occasional crouching, stooping, bending, and twisting of upper body and neck
- Ability to access and use in-house and off-the-shelf computer software
- Ability to lift and carry 15-20 lbs.
- Regular and consistent attendance
- Varied hours may be required
Benefits
Comp & perks- 40-50% overnight travel
- Frequent travel to client/site locations, including occasional domestic and international travel
