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CRA II – Multi Sponsor
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 qualification, monitoring, and management within clinical trials, ensuring compliance with Good Clinical Practice and regulatory requirements. Proficient in clinical data handling, documentation, and audit readiness, with strong communication and interpersonal skills to effectively liaise with study site personnel.
Highest-signal resume keywords
Site QualificationGood Clinical Practice/ICH GuidelinesClinical Data ManagementAudit ReadinessInvestigational Product Management
ATS Keywords
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Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site InitiationInterim MonitoringSource Document ReviewElectronic Data Capture ComplianceClinical Trial DocumentationProtocol Deviations AssessmentPharmacovigilanceInventory ReconciliationData CollectionChart Abstraction
Soft Skills
Excellent CommunicationPresentation SkillsInterpersonal Skills
Tools & Technologies
EDC SystemsTrial Master FilesInvestigator Site Files
Certifications & Qualifications
Bachelor’s DegreeRN in a Related Field
Industry Keywords
Clinical TrialsRegulatory RequirementsSOPs/ProcessesPatient SafetySubject Recruitment
About the role
Key responsibilities & impact- Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely
- Evaluate site and site staff performance, communicate or escalate serious issues, and develop action plans
- Verify informed consent processes and protect subject/patient confidentiality
- Assess subject/patient safety, clinical data integrity, protocol deviations and pharmacovigilance issues
- Conduct source document review and verify clinical data entered in case report forms
- Resolve queries remotely and on site, guide site staff, and ensure closure within agreed timelines
- Use hardware and software for clinical study data review and capture; verify electronic data capture compliance
- Perform investigational product inventory, reconciliation and storage/security reviews as required
- Review Investigator Site Files and reconcile them with Trial Master Files
- Document activities through confirmation letters, follow-up letters, trip reports, communication logs and other project documents
- Support subject/patient recruitment, retention and awareness strategies
- Track observations, site status and action items to resolution
- Manage assigned site-level activities and communications to meet project scope, deliverables, budgets and timelines
- Act as primary liaison with study site personnel or collaborate with Central Monitoring Associates
- Ensure assigned sites and project-specific site team members are trained and compliant
- Prepare for and attend Investigator Meetings, sponsor meetings, global monitoring/project meetings and clinical training
- Provide site and project-level guidance for audit readiness and support audit preparation and follow-up
- For Real World Late Phase, support sites throughout the 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 out-of-scope activities, and suggest potential sites based on local knowledge
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 site qualification, initiation, monitoring, management and close-out activities
- Ability to work with clinical data, source documents, medical records, CRFs, EDC systems, ISF and TMF
- Ability to support investigational product inventory, reconciliation, storage, dispensing and administration verification
- Ability to prepare and maintain required clinical trial documentation
- Ability to support audit readiness and follow-up actions
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Collaboration with colleagues across the world
- Remote work arrangement (Remote (Pre-Approved))