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About the Role
The Clinical Research Associate 2 is a key member of the Clinical Operations group, responsible for site management, monitoring, and operational support of clinical trials. This role ensures compliance with regulatory requirements and SOPs, contributing to the successful implementation of project plans.
Responsibilities
- Coordinate the identification, feasibility assessment, and selection of investigators and sites.
- Complete all monitoring activities per the Monitoring Plan, including visit reports, accurately and on time.
- Prepare, plan, organize, and conduct site evaluation visits and report on these visits.
- Prepare, submit, and/or liaise with regulatory specialists regarding regulatory packages, importation/exportation requirements, and Ethics Committee updates.
- Negotiate site budgets, coordinate contract execution, track invoicing, and ensure timely site payments.
- Prepare, plan, organize, and conduct site initiation visits.
- Develop and maintain appropriate monitoring tools and project-specific documents.
- Motivate and train investigators and site personnel on protocol, investigational product, and trial requirements.
- Collect, review, and approve essential documents from trial sites for quality and compliance.
- Code documents for Trial Master File (TMF) filing.
- Reconcile contents of in-house TMF and site’s Investigator Site Files.
- Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies.
- Maintain trial information using the clinical trial management system and other tracking/reporting tools.
- Support strategies to boost recruitment efforts.
Requirements
- Tertiary qualifications in a related science or health care discipline.
- More than 2 years of experience in on-site monitoring and site management within an academic, CRO, or pharmaceutical environment is mandatory.
- Demonstrate practical knowledge of ICH-GCP guidelines and global and local ethical and regulatory research requirements.
- Display 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.
- Demonstrate competence in negotiation and conflict resolution, critical thinking, problem-solving, decision making, and strategic thinking.
- Demonstrate solid interpersonal communication, presentation skills, and flexibility to work within a multi-disciplinary team both autonomously and with varying stakeholders.
- Ability to be flexible and adaptable in the face of changing organizational priorities and ambiguous environments.
- Ability and willingness to travel.
Skills
- ICH-GCP guidelines
- Ethical and regulatory research requirements
- Ethical and participant safety considerations
- Site start-up management
- Site conduct management
- Risk management
- Quality management
- Supply management
- Scientific concepts
- Clinical research design
- Issue escalation management
- Negotiation
- Conflict resolution
- Critical thinking
- Problem-solving
- Decision making
- Strategic thinking
- Interpersonal communication
- Presentation skills
- Flexibility
- Adaptability
Location
- Singapore
Work Type
- Hybrid
- Remote
Experience Level
- 2+ years
Education Level
- Tertiary qualifications in a related science or health care discipline
Benefits
- Competitive Compensation
- Flexibility
- Career Growth
- Employee Wellbeing
- Global Opportunities
About the Company
- Emerald Clinical Trials is a global leader in clinical research, partnering with over 160 biotech companies and 15 of the world’s top 20 pharmaceutical firms.
- Headquartered in Singapore, we combine scientific excellence with operational expertise to deliver end-to-end clinical trial solutions across all phases, offering Phase I-IV and real-world studies.
- With over 25 years of experience and a world-renowned focus in renal research, Emerald Clinical has helped drive medical breakthroughs through deep scientific insight, flawless execution, and an unwavering commitment to quality.
- Global Expertise. Local Insight. Real Impact.
- Emerald Clinical is where science, speed, and strategy come together to transform healthcare.
- For over 25 years, we have led the way in clinical research, combining global reach with deep Asia-Pacific expertise and unparalleled local insight to deliver smarter trials and stronger outcomes.
- Our 1000+ employees that span across Asia-Pacific, Europe, and the Americas are embedded in communities worldwide.
- We drive faster recruitment, deeper patient engagement, and meaningful results that move medicine forward.
Equal Opportunity
- We are an equal-opportunity employer and encourage applications from all qualified candidates.