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CRA II – Sponsor-dedicated
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, site management, and compliance with Good Clinical Practice/ICH Guidelines. Proficient in managing investigational product inventory and ensuring data integrity throughout the clinical trial lifecycle.
Highest-signal resume keywords
Clinical MonitoringSite ManagementGood Clinical Practice/ICH GuidelinesData Integrity VerificationInvestigational Product Management
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 QualificationSource Document ReviewClinical Data Accuracy VerificationChart AbstractionData CollectionElectronic Data Capture ComplianceSite Staff TrainingAction Plan DevelopmentPatient Recruitment StrategiesRegulatory Compliance
Soft Skills
Excellent CommunicationPresentation SkillsInterpersonal SkillsProblem-SolvingCollaboration
Tools & Technologies
Trial Master FilesInvestigator Site FilesElectronic Data Capture SystemsCommunication Logs
Certifications & Qualifications
Bachelor’s DegreeRN in a Related Field
Industry Keywords
Clinical TrialsSite Management ActivitiesRegulatory RequirementsAudit ReadinessPatient Confidentiality
About the role
Key responsibilities & impact- Perform site qualification, site initiation, interim monitoring, site management activities and close-out visits
- Evaluate site and site staff performance and provide recommendations regarding site-specific actions
- Escalate serious issues to the project team and develop action plans
- Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity
- Conduct source document review and verify clinical data accuracy and completeness
- Resolve queries remotely and on site within agreed timelines
- Verify compliance with electronic data capture requirements
- Manage investigational product inventory, reconciliation, storage, dispensing and administration checks
- Review Investigator Site Files and reconcile them with Trial Master Files
- Document activities through confirmation letters, follow-up letters, trip reports and communication logs
- Support subject/patient recruitment, retention and awareness strategies
- Track observations, ongoing status and action items to resolution
- Manage site-level activities, communications, project objectives, deliverables and timelines
- Act as liaison with study site personnel and ensure site team training and compliance
- Attend investigator, sponsor and global clinical monitoring meetings and training sessions
- Support audit readiness and audit follow-up actions
- Support sites throughout the real world late phase study lifecycle
- Perform chart abstraction and data collection
- Collaborate with sponsor affiliates, medical science liaisons and local country staff
- Train junior staff when requested
- Identify and communicate out-of-scope activities
- Suggest potential sites based on local treatment patterns, patient advocacy and HCP associations
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
- Opportunity to collaborate with colleagues across the world