Clinical Research Associate 2

Emerald Clinical

Clinical Research Associate monitoring and managing Taiwan clinical trials for global CRO Emerald Clinical Trials. Coordinating sites, regulatory submissions, trial documentation, supplies, payments, and recruitment.

Posted 8/10/2026full-time🇲🇾 Malaysia, 🇹🇼 TaiwanJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial management, including site selection, monitoring, and regulatory compliance. Proficient in ICH-GCP guidelines and possesses strong negotiation, problem-solving, and interpersonal communication skills.

Highest-signal resume keywords

Clinical Trial ManagementSite MonitoringRegulatory ComplianceNegotiation SkillsInterpersonal Communication

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

On-Site MonitoringSite ManagementRisk ManagementQuality ManagementClinical Research DesignTrial Master File ManagementBudget NegotiationEthics Committee SubmissionRecruitment StrategiesInvestigational Product Handling

Soft Skills

Critical ThinkingProblem-SolvingDecision MakingStrategic ThinkingFlexibility

Tools & Technologies

Clinical Trial Management SystemMonitoring ToolsTracking/Reporting Tools

Industry Keywords

ICH-GCP GuidelinesRenal Clinical TrialsOncology Clinical TrialsEthical Research RequirementsParticipant Safety Considerations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Coordinate the identification, feasibility assessment, and selection of investigators and trial sites.
Complete monitoring activities according to the Monitoring Plan and prepare timely monitoring visit reports.
Plan, organize, and conduct site evaluation visits and report findings for site selection.
Prepare and submit regulatory packages, importation/exportation requirements, and Ethics Committee package updates, liaising with regulatory specialists.
Negotiate site budgets, coordinate site contract execution, track invoicing, and ensure timely site payments.
Plan, organize, and conduct site initiation visits.
Develop and maintain monitoring tools and project-specific documents.
Motivate and train investigators and site personnel on the protocol, investigational product, and trial requirements.
Collect, review, approve, and code essential site documents for Trial Master File filing.
Reconcile the in-house Trial Master File with Investigator Site Files.
Coordinate distribution, tracking, handling, and destruction of investigational products and trial supplies.
Maintain trial information in the clinical trial management system and tracking/reporting tools.
Support strategies to increase recruitment efforts.

Requirements

What you’ll need

Tertiary qualifications in a related science or health care discipline.
More than 2 years’ experience in on-site monitoring and site management within an academic, CRO, or pharmaceutical environment is mandatory.
Experience in renal and/or oncology clinical trials is a plus.
Practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements.
Competence in ethical and participant safety considerations, site start-up management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.
Competence in negotiation and conflict resolution, critical thinking, problem-solving, decision making, and strategic thinking.
Solid interpersonal communication and presentation skills.
Flexibility to work within a multi-disciplinary team autonomously and with varied stakeholders.
Ability to adapt to changing organizational priorities and ambiguous environments.
Ability and willingness to travel.

Benefits

Comp & perks

Competitive Compensation: A tailored salary and benefits package to reflect your skills and experience.
Flexibility: Enjoy hybrid or remote working arrangements, depending on your location and role.
Career Growth: Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
Employee Wellbeing: Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
Global Opportunities: Exposure to diverse projects and clients through the company’s international reach.
Purpose-driven work contributing to clinical trials that improve lives.
Collaboration and innovation culture valuing diverse perspectives and creative solutions.