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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 support, including document management, regulatory compliance, and monitoring activities. Proficient in maintaining project tracking tools and collaborating effectively with study teams and external stakeholders.
Highest-signal resume keywords
Clinical Trial SupportDocument ManagementRegulatory ComplianceICH GCP GuidelinesCollaboration Skills
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 Research ProcessDocument ReviewData MonitoringTrial Master File ManagementInformed Consent Form DevelopmentSite Regulatory Document ReviewCTMS MaintenanceQuery ResolutionOn-Site MonitoringRemote Monitoring
Soft Skills
Attention to DetailCritical ThinkingAdaptabilityCommunication SkillsIntegrity
Tools & Technologies
CTMSProject Tracking Tools
Industry Keywords
CROPharmaBiotechFederal RegulationsEthics Submission Processes
About the role
Key responsibilities & impact- Support the Project Manager, traveling CRAs, and Lead CRA on clinical trials
- Ensure monitoring activities are properly supported
- Track, collect, and review critical documents
- Collect, track, and review investigational site records related to subject screening and enrollment
- Assist in developing study plans and status reports
- Collect, track, and review site regulatory documents
- Assist with developing and reviewing Informed Consent Forms
- Interact with sites, clients, vendors, and internal study team members
- Maintain the CTMS and other project tracking tools
- Track study supplies and coordinate shipments to sites as needed
- Manage the study Trial Master File and ensure periodic TMF audits
- Coordinate work with CRAs conducting on-site monitoring
- Perform on-site co-monitoring and remote monitoring activities
- Review data entered by investigational site staff according to data review and monitoring guidelines
- Assist CRAs with query resolution and data reviews
- Ensure studies operate in compliance with study protocols, Rho SOPs, ICH/GCP guidelines, and federal regulations
- Potentially mentor other team members
Requirements
What you’ll need- Bachelor's degree in a life science, nursing, or pharmacy field
- At least 1 year of direct work experience managing essential documents within the CRO, pharma, or biotech industry
- Good knowledge of the clinical research process
- Understanding of regulatory and central/local ethics submission processes for assigned countries
- Working knowledge of current ICH GCP guidelines and applicable regulations
- Desire or career goal of growing into a traveling CRA role
- Strong written, verbal, and presentation skills
- Fluency in both the local language and English
- Attention to detail and commitment to high-quality scientific standards
- Ability to work collaboratively with honesty and integrity
- Critical thinking and objective evaluation skills
- Ability to adapt quickly to changing environments
- Resume/CV must be submitted in English
Benefits
Comp & perks- Work-life balance flexibility
- Supportive, collaborative work environment
- Financial, workforce, and corporate stability
- Career growth and development opportunities
- Opportunity to gain experience toward a traveling CRA role
- Potential mentoring opportunities