job description
Join Mandaya Hospital Group, a pioneer in healthcare excellence, as a Clinical Research Coordinator in the vibrant heart of Bali. This is a unique opportunity to contribute to groundbreaking clinical studies that shape the future of medical research while working in one of Indonesia’s most dynamic and culturally rich regions.
As a Clinical Research Coordinator, you will play a pivotal role in managing clinical trials from inception to completion, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to deliver high-impact research outcomes. Your expertise will drive the success of studies that advance medical knowledge and improve patient care.
Based in Denpasar, Badung, this role offers the perfect blend of professional growth and an unparalleled lifestyle in Bali—where innovation meets paradise. Whether you’re coordinating with investigators, managing data, or ensuring ethical compliance, your work will have a lasting impact on global healthcare.
Responsibility
- Coordinate and oversee clinical research studies from start-up to close-out, ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements.
- Liaise with principal investigators, research staff, and sponsors to facilitate study initiation, enrollment, and monitoring.
- Develop and maintain study documentation, including informed consent forms, case report forms (CRFs), and regulatory submissions.
- Monitor study progress, track participant recruitment, and ensure timely data collection and reporting.
- Conduct site visits, audits, and inspections to verify compliance with study protocols and applicable regulations.
- Manage study budgets, contracts, and vendor relationships to ensure efficient resource allocation.
- Train and supervise research staff on study procedures, data management, and ethical considerations.
- Prepare and submit progress reports, safety reports, and final study documentation to sponsors and regulatory authorities.
Qualifications
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or a related field. Advanced degrees (e.g., Master’s in Clinical Research) are a plus.
- Minimum 3 years of experience as a Clinical Research Coordinator, Clinical Research Associate (CRA), or in a similar role within a hospital, CRO, or pharmaceutical setting.
- In-depth knowledge of ICH-GCP guidelines, local regulatory requirements (e.g., BPOM), and ethical standards in clinical research.
- Proven experience in study coordination, data management, and regulatory submissions for Phase I-IV clinical trials.
- Strong organizational, communication, and project management skills with the ability to multitask in a fast-paced environment.
- Proficiency in clinical trial management systems (CTMS), EDC platforms, and Microsoft Office Suite.
- Fluency in English and Indonesian; additional languages are advantageous.
- Certification in Clinical Research (e.g., SOCRA, ACRP) is highly desirable.