job description
Join JobStudio as a Clinical Research Specialist in Bali and contribute to groundbreaking clinical research that drives meaningful improvements in patient care. This role offers a unique opportunity to collaborate with global sponsors and engage in cutting-edge studies that shape the future of healthcare.
As part of our dynamic team, you will play a pivotal role in ensuring the integrity, accuracy, and compliance of clinical trials. Your work will directly impact the development of life-saving treatments and innovative medical solutions. Bali’s vibrant and growing healthcare ecosystem provides an inspiring backdrop for professionals passionate about advancing medical research.
We are seeking a detail-oriented and motivated individual who thrives in a fast-paced, collaborative environment. If you are eager to make a difference in the field of clinical research while working in one of the world’s most sought-after destinations, this is the opportunity for you.
Responsibility
- Coordinate and monitor clinical trial activities to ensure compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- Liaise with investigators, sponsors, and research sites to facilitate smooth trial execution and data collection.
- Review and verify clinical trial data for accuracy, completeness, and adherence to study protocols.
- Prepare and submit regulatory documents, including ethics committee applications and study reports.
- Conduct site initiation, monitoring visits, and close-out activities to ensure trial integrity and participant safety.
- Maintain accurate and up-to-date trial documentation, including case report forms (CRFs) and essential study files.
- Collaborate with cross-functional teams to address and resolve trial-related issues or discrepancies.
- Stay abreast of industry trends, regulatory changes, and best practices in clinical research.
Qualifications
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field. Advanced degrees (e.g., Master’s, PhD) are a plus.
- Minimum of 2-3 years of experience in clinical research, trial coordination, or a related role within the healthcare or pharmaceutical industry.
- Strong knowledge of GCP, ICH guidelines, and local regulatory requirements for clinical trials.
- Excellent organizational, analytical, and problem-solving skills with a keen attention to detail.
- Proven ability to manage multiple priorities and meet tight deadlines in a fast-paced environment.
- Exceptional written and verbal communication skills in English; proficiency in Indonesian is advantageous.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
- Certification in clinical research (e.g., CCRP, CCRC) is highly desirable.