Clinical Research Specialist - Bali

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 work on cutting-edge clinical trials. As part of our dynamic team, you will play a crucial role in ensuring the success of our research projects from inception to completion.

Our company, JobStudio, is a leading player in the clinical research industry, known for our commitment to excellence and innovation. Located in the vibrant city of Bali, you will have the chance to work in a supportive and collaborative environment while enjoying the unique cultural experiences that Bali has to offer.

In this role, you will be responsible for managing and coordinating various aspects of clinical trials, including protocol development, site selection, patient recruitment, data management, and regulatory compliance. You will work closely with cross-functional teams, including clinical trial managers, data managers, and regulatory affairs specialists, to ensure the smooth execution of our research projects.

📋 Tanggung Jawab Pekerjaan

Key Responsibilities:

• Develop and manage clinical trial protocols, ensuring compliance with regulatory guidelines and industry standards.
• Coordinate with site investigators and monitor trial progress to ensure timely completion.
• Recruit and screen potential trial participants, ensuring eligibility and informed consent.
• Manage and analyze clinical trial data using specialized software such as SAS, SPSS, and Clinical Data Management Systems.
• Collaborate with global sponsors and regulatory authorities to ensure adherence to ethical and legal requirements.
• Prepare and submit regulatory submissions, including Investigational New Drug (IND) applications and protocol amendments.
• Conduct site visits and audits to monitor trial conduct and ensure compliance with protocol requirements.
• Provide training and support to site staff and trial participants to ensure a high standard of trial conduct.

🎓 Kualifikasi & Syarat

Kualifikasi & Syarat:

• Bachelor's degree in Clinical Research, Pharmacy, Medicine, or a related field.
• Minimum of 3 years of experience in clinical research, preferably in a regulatory or clinical operations role.
• Strong knowledge of clinical trial methodology, Good Clinical Practice (GCP), and regulatory requirements.
• Proficiency in English, both written and spoken.
• Experience with clinical trial data management software such as SAS, SPSS, or Clinical Data Management Systems.
• Certification in clinical research or a related field is a plus.
• Excellent organizational, analytical, and communication skills.
• Ability to work independently and as part of a team in a fast-paced environment.

🛠️ Keahlian

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