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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, compliance with ICH-GCP and local regulations, and effective collaboration with cross-functional teams. Proficient in managing clinical trial documentation and ensuring patient safety throughout the investigational process.
Highest-signal resume keywords
On-Site Monitoring ExperienceICH-GCP ComplianceCTMS ProficiencyETMF ManagementDrug Accountability
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 VisitsPatient Safety MonitoringData Query ResolutionSite Budget AssistanceTimely AE/SAE/PQC ReportingDocumentation ManagementCompliance Record MaintenanceSubject Recruitment Support
Soft Skills
CommunicationCollaborationProblem-SolvingAttention to DetailTraining Support
Certifications & Qualifications
Bachelor’s Degree in Life SciencesRegistered Nurse (RN) Qualification
Industry Keywords
Pharmaceutical IndustryCRO IndustryTherapeutic AreasRegulatory RequirementsClinical Trial Management
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 site staff training and maintain compliance records
- Monitor patient safety and ensure timely AE/SAE/PQC reporting
- Support subject recruitment and retention efforts
- 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 with site budgets and timely site payments
- Collaborate with CTAs, LTMs, CTMs, and other cross-functional partners
Requirements
What you’ll need- Bachelor’s degree in Life Sciences or equivalent, or qualified RN
- Eligible to work in the United States without visa sponsorship
- 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry
- Experience monitoring across multiple therapeutic areas
- Proficient in ICH-GCP, local regulatory requirements, CTMS, and eTMF
- Willing and able to travel up to 60%–75% for on-site monitoring visits across the Midwest region
- Preference for candidates residing in Chicago near major HUB airports
Benefits
Comp & perks- Competitive base salary and performance related incentives
- 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