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CRA II – Multisponsor
Syneos Health. Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in site management, regulatory compliance, and clinical data integrity while effectively communicating with study site personnel and managing project timelines and deliverables.
Highest-signal resume keywords
Site ManagementGood Clinical Practice/ICH GuidelinesOn-Site MonitoringRegulatory ComplianceClinical Data Integrity
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 QualificationSite InitiationSource Document ReviewCRF Data VerificationInvestigational Product ManagementTrial Master File ReconciliationAudit ReadinessChart AbstractionData CollectionSubject Recruitment Strategies
Soft Skills
Excellent CommunicationPresentation SkillsInterpersonal Skills
Tools & Technologies
Clinical Trial Management SystemsElectronic Data Capture Systems
Industry Keywords
Regulatory RequirementsSite ComplianceClinical TrialsInvestigator Site FilesSOPs
About the role
Key responsibilities & impact- Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely
- Ensure regulatory, ICH-GCP/GPP, protocol, and site compliance
- Evaluate site and staff performance and communicate or escalate serious issues
- Verify informed consent, subject safety, confidentiality, and clinical data integrity
- Conduct source document review and verify accurate and complete CRF data
- Resolve queries remotely and on-site within agreed timelines
- Manage investigational product inventory, reconciliation, storage, dispensing, and returns as applicable
- Review and reconcile Investigator Site Files with Trial Master Files
- Document monitoring activities through letters, trip reports, communication logs, and project documents
- Support subject recruitment, retention, and awareness strategies
- Track observations, status, and action items to resolution
- Manage site-level activities, communication, budgets, timelines, deliverables, and project objectives
- Liaise with study site personnel and ensure assigned sites and project team members are trained and compliant
- Attend investigator, sponsor, global monitoring, and clinical training meetings
- Support audit readiness, audit preparation, and follow-up actions
- For Real World Late Phase studies, support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff, identify out-of-scope activities, and suggest potential sites
Requirements
What you’ll need- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- +1 year of independent on-site monitoring
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Good computer skills and ability to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
- Working knowledge of relevant regulations and company SOPs/processes
- Completion of assigned training as required
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations when appropriate