job description
Join Tan Tock Seng Hospital, a premier healthcare institution, as a Senior Clinical Research Coordinator in the vibrant heart of Denpasar, Bali. This is a unique opportunity to drive impactful medical research while enjoying the tropical work-life balance Bali offers.
In this pivotal role, you will oversee the seamless execution of clinical trials and research projects, ensuring compliance with international standards (GCP/ICH) and local regulations. Your organizational prowess and attention to detail will be instrumental in coordinating multi-disciplinary teams, managing study documentation, and maintaining the highest ethical standards in patient-centered research.
Ideal for professionals passionate about advancing healthcare through meticulous research coordination, this position combines professional growth with the chance to live in one of Southeast Asia’s most dynamic locations.
Responsibility
- Lead the planning, execution, and monitoring of clinical research studies from initiation to close-out.
- Ensure strict adherence to Good Clinical Practice (GCP), ICH guidelines, and local regulatory requirements.
- Coordinate with principal investigators, research staff, and external stakeholders to meet study milestones.
- Develop and maintain study documentation, including protocols, case report forms, and regulatory submissions.
- Oversee participant recruitment, screening, and enrollment while ensuring ethical consent processes.
- Monitor study budgets, negotiate with vendors, and track expenditures to ensure financial compliance.
- Conduct site initiation visits, interim monitoring, and close-out activities to guarantee data integrity.
- Prepare and submit progress reports, safety reports, and final study documentation to sponsors and authorities.
Qualifications
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or related fields; Master’s degree preferred.
- Minimum 5 years of experience in clinical research coordination, with at least 2 years in a senior role.
- Certification in GCP/ICH or equivalent (e.g., SOCRA, ACRP) is highly advantageous.
- Proven track record of managing Phase I-IV clinical trials in a hospital or CRO setting.
- Excellent command of English (written and verbal) and proficiency in Indonesian (Bahasa) is a plus.
- Strong organizational, problem-solving, and interpersonal skills to liaise with diverse teams.
- Familiarity with EDC systems (e.g., Medidata Rave, Oracle Clinical) and CTMS.
- Ability to work independently in a fast-paced environment while maintaining attention to detail.