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CRA I
Syneos Health. Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical monitoring and site management, ensuring compliance with Good Clinical Practice and regulatory requirements while effectively managing site-level activities and communications. Proficient in supporting patient recruitment and retention strategies, as well as training site staff.
Highest-signal resume keywords
Clinical MonitoringSite ManagementGood Clinical Practice (GCP)Regulatory ComplianceCommunication 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
Site QualificationSite InitiationSource Document ReviewClinical Data IntegrityInvestigational Product ManagementTrial Master File ReconciliationChart AbstractionData CollectionClinical Monitoring ActivitiesSite Staff Training
Soft Skills
Excellent CommunicationPresentation SkillsInterpersonal Skills
Tools & Technologies
Clinical Trial Management SystemsProject Management Tools
Industry Keywords
ICH GuidelinesRegulatory RequirementsSite ComplianceAudit ReadinessPatient Confidentiality
About the role
Key responsibilities & impact- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits
- Ensure regulatory, ICH-GCP/GPP, protocol, and site compliance
- Evaluate site and site staff performance and communicate or escalate serious issues
- Verify informed consent processes, subject/patient confidentiality, safety, and clinical data integrity
- Conduct source document review and verify clinical data in case report forms
- Resolve queries remotely and on site and guide site staff
- Manage investigational product inventory, reconciliation, storage, dispensing, and returns
- Review Investigator Site Files and reconcile them with Trial Master Files
- Document monitoring activities through letters, trip reports, communication logs, and project documents
- Support subject/patient recruitment, retention, and awareness strategies
- Track observations, status, and action items to resolution
- Manage site-level activities, communications, project deliverables, budgets, and timelines
- Liaise with study site personnel and ensure site teams are trained and compliant
- Attend investigator, sponsor, global monitoring, and clinical training meetings
- Support audit readiness and audit 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, and identify potential sites
Requirements
What you’ll need- Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience
- 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
- Ability to perform clinical monitoring and site management activities on-site or remotely
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture