About Emerald Clinical
Emerald Clinical is a global, full-service Contract Research Organization (CRO) with deep-rooted expertise in the Asia-Pacific region. We are dedicated to advancing clinical research through scientific leadership and operational excellence, supporting biopharmaceutical, medical device, and diagnostic innovators across all phases—from registration to post-marketing.
Our specialized focus in renal, cardiometabolic, and oncology therapeutic areas allows us to make a profound impact on global health outcomes.
Our People-First Approach
Success in clinical research hinges on trust and connection. Our global teams work directly within local communities to build strong relationships, ensuring diverse patient recruitment and meaningful engagement. By prioritizing people at every step, we deliver higher-quality data and accelerate timelines, ultimately getting life-changing therapies to patients faster.
About the Role: Clinical Research Associate II (CRA II)
As a CRA II within our Clinical Operations group, you will be a pivotal driver of clinical trial execution and site management. This role is responsible for ensuring site compliance, patient safety, and data integrity, acting as the primary liaison between Emerald Clinical and our investigative sites.
Key Responsibilities
Site Management & Monitoring:
- Conduct all site monitoring activities (pre-study, initiation, routine, and close-out visits) in strict adherence to the Monitoring Plan, ICH-GCP, and SOPs.
- Prepare accurate and timely monitoring visit reports within the required timeframe.
- Collect, review, and approve essential documents to ensure site compliance and facilitate Trial Master File (TMF) readiness.
Site Selection & Start-Up:
- Coordinate site identification, feasibility assessments, and selection processes.
- Plan and conduct site evaluation and initiation visits.
- Prepare and submit regulatory and Ethics Committee packages in collaboration with regulatory specialists.
- Negotiate site budgets and contracts, and manage subsequent invoicing and payment tracking.
Operational Support & Trial Conduct:
- Develop and maintain project-specific monitoring tools and documents.
- Motivate, train, and support site staff to ensure a thorough understanding of the protocol and trial obligations.
- Reconcile the in-house TMF and site Investigator Site Files (ISF).
- Manage the distribution, tracking, and reconciliation of investigational product and trial supplies.
- Maintain accurate trial information in the Clinical Trial Management System (CTMS).
- Support site and sponsor teams with targeted patient recruitment strategies.
About You: Qualifications & Experience
Requirements:
- A tertiary degree in a life science, healthcare, or related discipline.
- 2-5 years of hands-on, on-site monitoring and site management experience within a CRO, pharmaceutical company, or academic research environment.
- Demonstrated, practical knowledge of ICH-GCP guidelines and local/global regulatory requirements.
- Proven competence in core monitoring skills: ethical/patient safety considerations, site start-up/conduct, risk/quality/supply management, and issue escalation.
- Strong business acumen in negotiation, conflict resolution, critical thinking, and strategic problem-solving.
- Excellent interpersonal, communication, and presentation skills; a collaborative team player capable of working autonomously and with diverse stakeholders.
- Flexibility and adaptability in a fast-paced, evolving environment.
- Willingness and ability to travel as required by trial assignments.
Preferred:
- Experience in Oncology and/or early-phase (Phase I/II) clinical trials.
- Experience working on global or multi-regional studies.
Why Join Emerald Clinical?
At Emerald Clinical, we believe transformative clinical research starts with our people. By joining our team, you become part of a global mission to improve patient lives through rigorous, ethical science.
What Makes Us Unique:
- Purpose-Driven Impact: Contribute directly to groundbreaking research in renal, cardiometabolic, and oncology fields.
- Global-Local Model: Leverage our international network while applying crucial local insights to build community trust and trial success.
- Collaborative Innovation: Work in a culture that champions diverse thought and creative solutions to the world’s most pressing health challenges.
What We Offer You:
- Competitive & Customized Package: A salary and benefits structure tailored to recognize your expertise and experience.
- Flexible Working: Hybrid or remote work arrangements to support your productivity and work-life balance.
- Career Acceleration: Access to continuous learning, professional development resources, and a global network of industry leaders.
- Holistic Wellbeing: Initiatives focused on your health, engagement, and connection, including global surveys, recognition programs, and team events.
- Global Scope: The opportunity to work on international projects, expanding your expertise and professional horizons.
Ready to advance clinical research with a team that puts people first?
Apply now to join Emerald Clinical as a CRA II and help us improve health for millions worldwide.
Emerald Clinical is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
