Remote/Onsite Clinical Research Associate — Site Lead

MSD Malaysia; Sydney; Hybrid; AUD 90,000 - 120,000; Full time

Job summary

MSD Malaysia in Sydney, Australia is seeking a Clinical Research Associate (CRA) for a permanent, full-time role. Location: Macquarie Park, Sydney, with home or office-based options depending on location.

The CRA will manage sites, ensure protocol conduct aligns with ICH-GCP and local laws, and support overall portfolio growth. Responsibilities include site monitoring, regulatory documentation collection, and collaboration across country operations.

Qualifications

• Clinical research knowledge with site management experience in pharma/CRO.
• 1
• Solid understanding of ICH-GCP and local regulations.
• 2
• Experience with regulatory documentation and site communications.
• 2
• Ability to ensure data integrity and safety across trials.
• 3
• Strong written and verbal English communication skills.

Responsibilities

• Act as primary site contact and site manager for allocated sites.
• Perform site monitoring and management activities per ICH-GCP and protocol.
• Coordinate readiness activities with sponsor functions and sites.
• Prepare visit and non-visit reports detailing findings and actions.
• Contribute to site selection, validation, and growth of the portfolio.
• Maintain documentation in CTMS/eTMF and ensure audits readiness.

Skills

Site management

ICH-GCP knowledge

Regulatory awareness

Data integrity

Audit readiness

Education

Associate degree in science

Bachelor's degree in life sciences

Tools

CTMS

eTMF

Microsoft Office

Job description

MSD Malaysia in Sydney, Australia is seeking a Clinical Research Associate (CRA) for a permanent, full-time role. Location: Macquarie Park, Sydney, with home or office-based options depending on location.

The CRA will manage sites, ensure protocol conduct aligns with ICH-GCP and local laws, and support overall portfolio growth. Responsibilities include site monitoring, regulatory documentation collection, and collaboration across country operations.