CRA I/II

Syneos Health

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

Posted 11/9/2026full-timeRemote • ChinaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical monitoring, site management, and regulatory compliance, with a strong focus on ICH-GCP guidelines and effective communication skills. Capable of managing investigational products and supporting clinical study processes while ensuring data integrity and audit readiness.

Highest-signal resume keywords

Clinical MonitoringSite ManagementICH-GCP GuidelinesRegulatory ComplianceData Integrity

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site QualificationSite InitiationSource Document ReviewElectronic Data Capture ComplianceClinical Data VerificationChart AbstractionData CollectionInvestigational Product ManagementProtocol ComplianceAction Plan Development

Soft Skills

Excellent CommunicationPresentation SkillsInterpersonal Skills

Tools & Technologies

Trial Master FilesInvestigator Site FilesMonitoring Documentation Tools

Certifications & Qualifications

Bachelor’s DegreeRN in Related Field

Industry Keywords

Good Clinical PracticeICH GuidelinesRegulatory RequirementsClinical Study LifecyclePatient Recruitment Strategies

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, protocol, and company SOP/process compliance
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
Verify clinical data in case report forms and resolve queries within agreed timelines
Support clinical study data review, capture, and electronic data capture compliance
Manage investigational product inventory, reconciliation, storage, dispensing, administration, labeling, and return as applicable
Review and reconcile Investigator Site Files with Trial Master Files and ensure essential-document archiving
Document monitoring activities through letters, trip reports, communication logs, and project documents
Support subject/patient recruitment, retention, and awareness strategies
Track observations, site status, action items, deliverables, budgets, and timelines
Liaise with study site personnel and ensure site/project team training and compliance
Attend investigator, sponsor, global monitoring, and clinical training meetings
Support audit readiness, audit preparation, and follow-up actions
For Real World Late Phase: support sites throughout the study lifecycle, collaborate with sponsor affiliates, medical science liaisons, and local country 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
Working knowledge of ICH/GCP Guidelines, applicable guidance, relevant regulations, and company SOPs/processes
Ability to perform clinical monitoring and site management activities on-site or remotely
For Real World Late Phase: knowledge of local requirements for real world late phase study designs
For Real World Late Phase: chart abstraction and data collection capabilities

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 (pre-approved)