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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in site monitoring and compliance with ICH-GCP and local regulations, with a strong focus on patient safety and data integrity in clinical trials. Proficient in managing clinical trial documentation and collaborating effectively with cross-functional teams.
Highest-signal resume keywords
On-Site Monitoring ExperienceICH-GCP ComplianceCTMS ProficiencyClinical Trial ManagementPatient Safety Monitoring
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 SelectionRoutine MonitoringClose-Out VisitsAE/SAE/PQC ReportingData Query ResolutionBudget TrackingDrug AccountabilityClinical Trial Documentation
Soft Skills
Clear CommunicationProblem-SolvingCollaboration
Tools & Technologies
CTMSETMF
Industry Keywords
Pharmaceutical IndustryCRO IndustryPhase I/II Clinical TrialsCompliance RecordsSite Staff Training
About the role
Key responsibilities & impact- Serve as the primary point of contact between investigational sites and the sponsor
- Conduct site selection, initiation, routine monitoring, and close-out visits
- Ensure site compliance with ICH-GCP, SOPs, and regulations
- Maintain documentation in CTMS and eTMF systems
- Support and track site staff training and maintain compliance records
- Monitor patient safety and ensure timely, accurate AE/SAE/PQC reporting
- Support subject recruitment and retention at the site level
- Oversee drug accountability and proper storage, return, or destruction
- Resolve data queries and drive timely, high-quality data entry
- Document site progress and escalate risks or issues to the clinical team
- Assist in tracking site budgets and timely site payments as applicable
- Collaborate with CTAs, LTMs, CTMs, and other cross-functional partners
Requirements
What you’ll need- A graduate with a Bachelor’s degree in Life Sciences or equivalent, or a qualified RN
- Eligible to work in United States without visa sponsorship
- 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
- Experience monitoring Phase I/II clinical trials
- Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
- Clear communicator, problem-solver, and collaborative team player
- Employment with ICON is contingent upon having the legal right to work in the country where the role is based
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways