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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 within the pharmaceutical industry, with a strong focus on ICH-GCP regulations and clinical systems management. Proven ability to manage site interactions, patient safety, and data integrity while supporting recruitment and retention efforts.
Highest-signal resume keywords
On-Site Monitoring ExperienceICH-GCP ComplianceCTMS and eTMF ProficiencyOncology Monitoring ExperienceSite Compliance Management
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 VisitsData EntryAdverse Event ReportingDrug AccountabilitySite Budget AssistancePatient Safety MonitoringRegulatory ComplianceTraining and Compliance Tracking
Soft Skills
CollaborationProblem-SolvingCommunicationRisk ManagementAttention to Detail
Industry Keywords
Pharmaceutical IndustryCROOncologyHemOncClinical TrialsInvestigational SitesSite Staff TrainingPatient RecruitmentSOPsRegulatory Requirements
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 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 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 Oncology (Prostate Cancer, and Lung Cancer) and HemOnc
- Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
- Willing and able to travel up to 60% - 75% for on-site monitoring visits across southeast region
- Preference given to candidates residing in Houston or New Orleans, preferably near major HUB airports
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