CRA II/Sr CRA - Oncology

Syneos Health

. Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely .

Posted 11/9/2026full-timeRemote • Oregon • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in site qualification, monitoring, and compliance with regulatory standards such as ICH-GCP/GPP. Proficient in managing clinical study activities, ensuring data integrity, and supporting patient recruitment and retention strategies.

Highest-signal resume keywords

Site QualificationRegulatory ComplianceClinical Data IntegrityGood Clinical Practice KnowledgeChart Abstraction Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site ManagementData CollectionSource Document ReviewCase Report Form VerificationInvestigational Product AdministrationAction Plan DevelopmentElectronic Data Capture ComplianceMonitoring Activity DocumentationTrial Master File ReconciliationPatient Safety Verification

Soft Skills

Excellent CommunicationInterpersonal SkillsPresentation SkillsTeam CollaborationTraining Ability

Tools & Technologies

Clinical Study Management SoftwareElectronic Data Capture SystemsMonitoring ToolsProject Management Tools

Certifications & Qualifications

Bachelor’s DegreeRegistered Nurse (RN)

Industry Keywords

ICH GuidelinesGood Clinical PracticeReal World Late Phase StudiesSite Personnel LiaisonAudit Readiness

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 and protocol compliance
Evaluate site and site staff performance and develop or escalate action plans
Verify informed consent, subject/patient safety and clinical data integrity
Assess site processes and conduct source document review and medical record review
Verify clinical data in case report forms and drive query resolution to closure
Support clinical study data review, capture and electronic data capture compliance
Perform investigational product inventory, reconciliation, storage, dispensing and administration reviews
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 through resolution
Manage site-level activities and communications against project scope, budgets, timelines and deliverables
Liaise with study site personnel and train assigned site/project team members
Attend investigator meetings, sponsor meetings, global project meetings and clinical training
Support audit readiness, audit preparation and follow-up actions
For Real World Late Phase: support sites throughout the study lifecycle, conduct 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
Must comply with site requests for medical and other personal information required for facility access as a condition of employment
For Real World Late Phase: knowledge of local requirements for real world late phase study designs
For Real World Late Phase: chart abstraction activities and data collection experience/knowledge
For Real World Late Phase: collaboration with Sponsor affiliates, medical science liaisons and local country staff

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