Senior Clinical Research Associate

Asahi Kasei

. Assist with all phases of clinical trial activities, including start-up, maintenance, and closeout .

Posted 10/8/2026full-timeCary • North Carolina • United StatesSenior💰 $100,000 - $115,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, including site monitoring, compliance oversight, and data integrity. Proficient in ICH GCP guidelines and regulatory requirements, with strong communication and problem-solving skills.

Highest-signal resume keywords

Clinical Trial ManagementSite Monitoring ExperienceICH GCP GuidelinesData Integrity ReviewMS Office Suite Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ActivitiesSite Performance OversightCentralized Data ReviewProtocol ComplianceTracking Spreadsheets ManagementTrial Master File ManagementSource Document VerificationSafety ReportingQuery ResolutionMonitoring Tools Review

Soft Skills

Superior Communication SkillsAttention to DetailProblem-Solving SkillsFlexibilityInitiative

Industry Keywords

Life Science DegreeClinical DegreeRegulatory GuidelinesFDAEMEAPMDA

About the role

Key responsibilities & impact

Assist with all phases of clinical trial activities, including start-up, maintenance, and closeout
Review site monitoring visit reports to identify potential site non-compliance and monitoring deficiencies and ensure sponsor oversight
Support essential document review
Perform centralized review of clinical data listings, EDC queries, protocol deviations, site metrics, and study dashboards
Assist the Clinical Project Manager by monitoring CRO monitor performance
Oversee site performance for protocol compliance, quality measures, scope of work, and timelines
Maintain tracking spreadsheets and databases
File and manage the Trial Master File and review investigator folders for required documents
Conduct proactive site interactions to encourage enrollment and timeline compliance
Demonstrate independent site management, including compliance, deliverables, relationships, and troubleshooting
Participate in trial meetings, including kick-off, investigator, and monitor meetings
Support operational study timeline and performance metric tracking and issue resolution
Review informed consents, case report forms, study operations manuals, monitoring tools, and related materials
Track site progress for timely data collection, source document verification, and query resolution
Ensure timely safety reporting at assigned investigative sites
Participate in data listings review

Requirements

What you’ll need

Life science degree, advanced scientific, or clinical degree or equivalent degree or experience
At least 3 years’ monitoring experience
Strong understanding of ICH GCP guidelines and region-specific regulatory guidelines, including FDA, EMEA, and PMDA
Ability to work with minimal supervision
Superior written and oral communication skills
Exceptional attention to detail and problem-solving skills
Flexibility to adapt to changing priorities and manage activities while maintaining quality
Ability to take initiative, prioritize, and execute tasks and special projects with minimal direction or supervision
Ability to maintain confidentiality, integrity, and discretion
Ability to work effectively across different levels and functions
Ability to travel domestically and internationally, as required
Proficient in MS Office Suite (Excel, Word, Outlook, PowerPoint)

Benefits

Comp & perks

Hybrid work arrangement
Limited domestic or international travel for investigator meetings, site engagement, or oversight activities
Equal opportunity employer commitment
Diverse workforce support