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CRA II/Sr CRA – Ophthalmology
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 site personnel and managing project deliverables. Proficient in Good Clinical Practice and capable of training site staff to ensure adherence to protocols and enhance patient recruitment strategies.
Highest-signal resume keywords
Site ManagementGood Clinical Practice (GCP)Clinical Data IntegrityRegulatory 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 ReviewCase Report Form VerificationElectronic Data Capture ComplianceInvestigational Product ManagementChart AbstractionData CollectionAction Plan DevelopmentMonitoring Activities Documentation
Soft Skills
Excellent CommunicationPresentation SkillsInterpersonal Skills
Tools & Technologies
Trial Master FilesInvestigator Site FilesClinical Monitoring Software
Certifications & Qualifications
Bachelor’s DegreeRegistered Nurse (RN)
Industry Keywords
ICH GuidelinesRegulatory RequirementsPatient SafetyAudit ReadinessSite Personnel Liaison
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 and provide site-specific recommendations and action plans
- Ensure regulatory, ICH-GCP/GPP and protocol compliance
- Verify informed consent processes, subject/patient safety and clinical data integrity
- Conduct source document review and medical record review
- Verify clinical data entered in case report forms and resolve queries
- Verify electronic data capture compliance
- Manage investigational product inventory, reconciliation, storage, dispensing and administration when 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/patient recruitment, retention and awareness strategies
- Track observations, site status and action items to resolution
- Manage site-level activities, communications, deliverables, budgets and timelines
- Liaise with study site personnel and Central Monitoring Associates
- Train assigned sites and project-specific site team members
- Attend investigator, sponsor and global clinical monitoring meetings and clinical training
- Support audit readiness, audit preparation and follow-up actions
- For Real World Late Phase, 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
- 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
- For US employment, required compliance with site requests for medical and other personal information needed for facility access
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Company car or car allowance
- Medical, Dental and Vision health benefits
- Company match 401k
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO)
- Sick time