job description
Join Changi General Hospital as a Clinical Research Coordinator in the vibrant heart of Denpasar, Bali. This contract role offers a unique opportunity to contribute to cutting-edge medical research while working in a dynamic, multicultural environment. As a key member of our research team, you will play a pivotal role in ensuring the smooth execution of clinical trials and studies, adhering to international standards and ethical guidelines.
Bali’s growing healthcare sector provides an exciting backdrop for professionals seeking to advance their careers in clinical research. Whether you are an experienced coordinator or a passionate newcomer, this position allows you to develop expertise in study management, regulatory compliance, and data integrity—all while enjoying the island’s renowned work-life balance.
At Changi General Hospital, we are committed to fostering innovation and excellence in healthcare. If you are detail-oriented, organized, and eager to make a meaningful impact in medical research, we invite you to apply and become part of our mission to improve patient outcomes through evidence-based practices.
Responsibility
- Coordinate and monitor clinical research studies in compliance with Good Clinical Practice (GCP) and regulatory requirements.
- Assist investigators in the preparation, submission, and maintenance of study documentation, including IRB/IEC applications and informed consent forms.
- Liaise with sponsors, CROs, and internal stakeholders to ensure timely study initiation, enrollment, and completion.
- Conduct source document verification and ensure accurate data collection, entry, and reporting in electronic data capture (EDC) systems.
- Schedule and facilitate study visits, including screening, enrollment, and follow-up assessments for research participants.
- Maintain study files, including regulatory binders, case report forms (CRFs), and essential documents, ensuring audit readiness.
- Provide training and support to study staff on protocol requirements, SOPs, and research best practices.
- Track and report adverse events (AEs) and serious adverse events (SAEs) in accordance with protocol and regulatory timelines.
Qualifications
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related healthcare field. Advanced degrees (e.g., Master’s in Clinical Research) are a plus.
- Minimum 2 years of experience in clinical research coordination, preferably in a hospital or CRO setting.
- Certification in GCP (Good Clinical Practice) and familiarity with ICH guidelines.
- Strong knowledge of regulatory requirements (e.g., FDA, EMA, local ethics committees) for clinical trials.
- Proficiency in EDC systems (e.g., Medidata Rave, REDCap) and Microsoft Office Suite.
- Excellent organizational, communication, and interpersonal skills to manage multiple studies and stakeholders.
- Ability to work independently and collaboratively in a fast-paced, multicultural environment.
- Fluency in English (written and verbal); knowledge of Indonesian (Bahasa) is advantageous.