Job Description Senior Clinical Research Associate (Sr. CRA)
The Senior Clinical Research Associate is responsible for the performance, quality, and compliance of assigned clinical trial sites and protocols within the country. Acting as the primary point of contact for investigators and site staff, the Sr. CRA oversees site activities throughout the study lifecycle, ensuring adherence to ICH-GCP, local regulations, and company standards. The role collaborates closely with cross-functional teams and external stakeholders to support successful study execution while driving site performance, recruitment, and operational excellence. The Sr. CRA also serves as a subject matter expert, sharing best practices, supporting audits and inspections, mentoring junior CRAs, and identifying new site opportunities to strengthen clinical research capabilities.
Responsibilities
- Site selection
- start-up
- monitoring
- regulatory document management
- issue resolution
- data quality oversight
- patient safety protection
- site close-out activities

Qualifications




- Candidates must hold a Bachelor’s degree (or higher) and;
- Have at least 4 years of direct site management (monitoring) experience in a pharmaceutical, biotechnology, or CRO environment.
- Strong communication, problem-solving, and organizational skills are essential, along with the ability to work independently in a dynamic environment.
- Domestic and international travel of up to 65-75% may be required

Required Skills
- Accountability
- Accountability
- Adaptability
- Adverse Event Report
- Clinical Data Management
- Clinical Development
- Clinical Reporting
- Clinical Research
- Clinical Research Organizations (CRO) Management
- Clinical Study Management
- Clinical Trial Compliance
- Clinical Trial Development
- Clinical Trial Documentation
- Clinical Trial Management
- Clinical Trial Planning
- Clinical Trials Monitoring
- Customer Auditing
- Customer-Focused
- Drug Development
- Good Clinical Data Management Practi

📌 Senior Clinical Research Associate (Santiago)
🏢 MSD Malaysia
📍 Santiago