Clinical Research Associate - Site Start-Up & Regulatory

Boston Scientific Gruppe; Kuala Lumpur; On-site; MYR 60,000 - 90,000; Full time

Job summary

Boston Scientific Malaysia in Kuala Lumpur is seeking a Clinical Research Associate to support the Global Clinical Operations Center of Excellence. The role focuses on site start-up, regulatory submissions, and data quality, partnering with cross‑functional teams to accelerate studies.

You will coordinate regulatory documents, manage eTMF records, and monitor IRB/EC timelines while upholding ICH/GCP, MDR and GDPR compliance. A degree in science and 2–3 years of CRA experience are required.

Qualifications

• Degree in a relevant scientific/healthcare field.
• 2–3 years of CRA/Start-up experience or similar.
• Familiarity with CTMS and eTMF systems.
• Strong communication with site personnel.
• Ability to work independently and in a team.

Responsibilities

• Coordinate site regulatory submissions and document collection.
• Document management across multiple studies.
• Collaborate to customize Informed Consent Forms (ICF).
• Develop relationships with internal customers and sites.
• Track IRB/EC timelines and startup challenges.
• Prepare and track regulatory, ICF, and legal docs.
• Assist with internal quality audits and inspections.
• Maintain startup/close-out trackers and eTMF metrics.
• Provide updates to leadership on site startup activities.
• Ensure adherence to ICH/GCP, MDR, GDPR and SOPs/WIs.

Skills

Regulatory submissions

Clinical site coordination

Document management

Communication skills

Independent worker

Education

Degree in science/healthcare

Tools

Siebel CTMS

Veeva

eTMF systems

Job description

Boston Scientific Malaysia in Kuala Lumpur is seeking a Clinical Research Associate to support the Global Clinical Operations Center of Excellence. The role focuses on site start-up, regulatory submissions, and data quality, partnering with cross‑functional teams to accelerate studies.

You will coordinate regulatory documents, manage eTMF records, and monitor IRB/EC timelines while upholding ICH/GCP, MDR and GDPR compliance. A degree in science and 2–3 years of CRA experience are required.