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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 and site management, with a strong understanding of ICH GCP guidelines and regulatory requirements. Proficient in data integrity, oversight monitoring, and effective communication with site personnel and study teams.
Highest-signal resume keywords
Clinical Trial MonitoringICH GCP GuidelinesData IntegritySite ManagementAnalytical Problem-Solving
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 QualificationDrug AccountabilityStudy DocumentationSource Documentation ReviewProtocol Deviation Tracking
Soft Skills
Effective CommunicationInterpersonal SkillsCritical ThinkingTime ManagementPrioritization
Tools & Technologies
Microsoft OfficeEDCCTMSData Repositories
Industry Keywords
Clinical Drug DevelopmentRegulatory RequirementsFDAEMAPMDA
About the role
Key responsibilities & impact- Support monitoring and site management activities for client-sponsored studies
- Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely
- Partner with Clinical Trial Liaison and client functions to support site activation and deliverables
- Establish and maintain relationships with investigator site staff
- Perform drug accountability, reconciliation, and destruction
- Prepare and maintain Oversight Monitoring Plan
- Review study metrics and assess CRO CRA and investigator site performance
- Conduct oversight monitoring visits independently or alongside CRO CRA
- Review source documentation and verify accurate data capture according to ALCOA principles
- Report study conduct status and follow up on issues and action items
- Maintain site regulatory files and verify timely submission of study documentation, including safety reporting
- Write monitoring visit reports, oversight monitoring visit reports, and study correspondence
- Identify, record, track, trend, and escalate protocol deviations and study-related issues
- Maintain communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs
- Participate in team meetings and process improvement initiatives
- Support inspection readiness activities and ensure data integrity and protocol deliverables
Requirements
What you’ll need- Bachelor's degree (or equivalent)
- Minimum of 5 years of related experience for Snr CRA
- Strong analytical problem-solving skills and critical thinking abilities
- Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA)
- Effective communication and interpersonal skills to build relationships internally and externally
- Familiarity with medical terminology
- Proficiency in Microsoft Office, EDC, CTMS, and data repositories
- Demonstrated ability to deliver clear and concise written reports
- Effective prioritization and time management skills
Benefits
Comp & perks- Equal opportunity employer
- Consideration without regard to legally protected status