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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial monitoring, including compliance with CFR and ICH/GCP guidelines, and proficiency in managing clinical sites and investigator training. Strong ability to evaluate clinical data, maintain regulatory files, and collaborate effectively with medical professionals.
Highest-signal resume keywords
Phase I Clinical Trial Monitoring Experience4+ Years CRA Monitoring ExperienceProficiency in Electronic Data Capture (EDC)Proficiency in Clinical Trial Management System (CTMS)Oncology/Immunology Experience
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 MonitoringSource Data ReviewDrug AccountabilityRegulatory ComplianceData Entry and Query ResolutionSite Initiation and Close-Out VisitsProtocol Compliance MonitoringEssential Document ReviewQuality AuditsIssue Resolution
Soft Skills
Excellent Communication SkillsOrganizational SkillsProblem-Solving AbilityFlexibilityAbility to Prioritize Workload
Tools & Technologies
Electronic Trial Master File (eTMF)Microsoft Office ProductsClinical Trial Management System (CTMS)
Certifications & Qualifications
RN or Health Care Professional Preferred
Industry Keywords
CFR ComplianceICH/GCP GuidelinesPharmaceutical ExperienceBiotech ExperienceFDA/EMEA Inspection ReadinessGlobal Clinical Trials
About the role
Key responsibilities & impact- Monitor and manage clinical sites in compliance with CFR and ICH/GCP guidelines
- Evaluate, initiate, monitor, and close clinical sites
- Identify and qualify potential investigators
- Perform pre-study, site initiation, interim monitoring, and close-out visits
- Assist with site start-up, essential document review, and collection
- Train investigators and site staff on protocols, procedures, documentation, and regulatory requirements
- Monitor protocol and GCP compliance
- Perform source data review and verify clinical data against source documents
- Ensure timely data entry and query resolution
- Perform drug accountability and ensure adequate drug supply
- Review research specimen documentation, storage, processing, and shipment
- Collaborate with drug safety on serious adverse event reporting
- Maintain complete and accurate site regulatory files and monitor IRB compliance
- Track and report study progress, protocol variations, issue resolution, and follow-up compliance
- Prepare visit reports, confirmation letters, and follow-up letters
- Maintain the Clinical Trial Management System (CTMS)
- Resolve site issues and action items or escalate them per the Clinical Monitoring Plan
- Assist Data Management and provide co-monitoring support
- Contribute to quality audits, department initiatives, study documents, and vendor management or data review activities
- Attend required staff meetings and training
- Complete required training, timesheets, expense reports, and CV updates
Requirements
What you’ll need- Phase I clinical trial monitoring experience required
- 4+ years of prior CRA monitoring experience in a CRO or Pharma organization required
- Bachelor of Arts/Science (BA/BS), or equivalent, or relevant experience and training with at least six (6) years of pharmaceutical/biotech experience
- Proficiency in written and spoken English required
- Proficiency in local languages, as applicable
- Willingness and ability to travel 55–75%
- Previous experience with Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and CTMS systems
- Proficiency with Microsoft Office Products: Word, Excel, PowerPoint, SharePoint
- Excellent communication and organizational skills
- Ability to discuss scientific, medical, and therapeutic area information with medical professionals
- Ability to manage multiple tasks, prioritize workload, and solve problems simultaneously
- Flexibility toward work assignments, learning, and travel
- RN or health care professional preferred
- Oncology/immunology experience preferred
- Experience on global clinical trials preferred
- FDA/EMEA inspection readiness preferred
Benefits
Comp & perks- Full-time employment
- Equal opportunity employment