CRA II

Syneos Health

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

Posted 11/12/2026full-timeTaipei • TaiwanMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in site qualification, monitoring, and management while ensuring compliance with ICH-GCP/GPP and regulatory standards. Proficient in clinical data integrity, subject safety assessments, and effective communication with study site personnel.

Highest-signal resume keywords

Site QualificationICH-GCP ComplianceClinical Data IntegritySubject Safety AssessmentSite Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Site InitiationInterim MonitoringSource Document ReviewData CollectionChart AbstractionRegulatory ComplianceElectronic Data CaptureInvestigational Product ManagementProtocol Deviation AssessmentAudit Readiness

Soft Skills

Excellent CommunicationInterpersonal SkillsPresentation SkillsCollaboration

Tools & Technologies

Trial Master FileInvestigator Site FilesClinical Monitoring Tools

Certifications & Qualifications

Bachelor’s DegreeRN in Related Field

Industry Keywords

Good Clinical PracticeICH GuidelinesRegulatory RequirementsReal World Late Phase StudiesPharmacovigilance

About the role

Key responsibilities & impact

Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits on-site or remotely
Ensure regulatory, ICH-GCP/GPP, and protocol compliance
Evaluate site and site staff performance and recommend site-specific actions
Escalate serious issues and develop action plans
Verify informed consent processes and protect subject/patient confidentiality
Assess subject safety, clinical data integrity, protocol deviations, violations, and pharmacovigilance issues
Conduct source document review and verify clinical data accuracy and completeness
Resolve queries remotely and on site within agreed timelines
Verify electronic data capture compliance
Manage investigational product inventory, reconciliation, storage, security, dispensing, and administration as applicable
Review and reconcile Investigator Site Files with the Trial Master File
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 assigned site-level activities, communications, deliverables, budgets, and timelines
Liaise with study site personnel and ensure site team training and compliance
Attend investigator, sponsor, clinical monitoring, project staff, and training meetings
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 as requested, 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
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 knowledge
Ability to collaborate 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
Total rewards program
Inclusive culture
Reasonable accommodations, when appropriate