Single Sponsor CRA II

Syneos Health

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

Posted 11/11/2026full-timeRemote • PolandMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in site management, clinical data integrity, and compliance with Good Clinical Practice/ICH Guidelines. Proficient in managing site-level activities, ensuring effective communication, and supporting audit readiness throughout the study lifecycle.

Highest-signal resume keywords

Site QualificationClinical Data IntegrityGood Clinical Practice/ICH GuidelinesSite ManagementPatient Recruitment Strategies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site InitiationSource Document ReviewCase Report Form VerificationElectronic Data Capture ComplianceInvestigational Product Inventory ManagementClinical Study Data ReviewMedical Record ReviewAction Plan DevelopmentProtocol ComplianceChart Abstraction

Soft Skills

Excellent Communication SkillsInterpersonal SkillsPresentation SkillsProblem-Solving SkillsTeam Collaboration

Tools & Technologies

Trial Master FilesInvestigator Site FilesElectronic Data Capture SystemsMonitoring Documentation Tools

Certifications & Qualifications

Bachelor’s DegreeRegistered Nurse (RN)

Industry Keywords

Clinical TrialsRegulatory ComplianceAudit ReadinessSite MonitoringPatient Confidentiality

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 recommendations and action plans
Verify informed consent, subject/patient confidentiality, safety, protocol compliance, and clinical data integrity
Assess site processes and conduct source document review and medical record review
Verify clinical data in case report forms and resolve queries within agreed timelines
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, site status, and action items to resolution
Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines
Liaise with study site personnel and ensure assigned sites and project team members are trained and compliant
Attend investigator, sponsor, clinical monitoring, project staff, and training meetings
Support audit readiness, audit preparation, and follow-up actions
For Real World Late Phase activities, 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

Benefits

Comp & perks

Career development and progression
Supportive and engaged line management
Technical and therapeutic area training
Peer recognition
Total rewards program
Inclusive culture
Reasonable accommodations when appropriate