Job Title: Senior Clinical Research Associate (Senior CRA)
Location: Malaysia (Various Sites)
Job Type: Full-Time
Travel Requirement: Approximately 60% (domestic and international)
Role Overview:
As a Senior Clinical Research Associate, you will manage and oversee clinical trial activities across multiple sites, ensuring high standards in data quality, participant safety, and regulatory compliance. This role includes advanced site monitoring, leadership responsibilities, and extensive collaboration with site staff and internal teams.
Primary Responsibilities:
- Advanced Site Monitoring: Lead site qualification, initiation, monitoring, and close-out visits, addressing complex issues and ensuring adherence to industry SOPs and regulatory guidelines.
- Cross-Functional Collaboration: Work with site staff and internal teams to ensure smooth trial operations and resolve any issues promptly.
- Mentorship and Training: Provide mentorship to junior clinical staff, support staff training, and offer guidance on best practices in monitoring.
- Data Integrity and Compliance Oversight: Ensure data quality and adherence to regulatory requirements, providing corrective guidance when necessary.
- Study Leadership: Take on lead roles in studies, overseeing additional study management responsibilities as required.
- Stakeholder Management: Maintain effective relationships with site personnel, investigators, and other stakeholders to facilitate study operations.
- Drug Accountability: Manage investigational product storage and documentation according to regulatory and study requirements.
Candidate Requirements:
- Education: Advanced degree in life sciences, nursing, or a related field preferred.
- Experience: Extensive experience as a Clinical Research Associate, with strong knowledge of clinical trial processes and regulations.
- Skills: Excellent communication and leadership skills, with strong organizational and problem-solving abilities.
- Technical Proficiency: Skilled in clinical trial software, SOPs, and monitoring tools.
Additional Information:
- Role requires travel up to 60%, including domestic and international sites.
- Dedication to quality improvement, client service, and high standards in clinical trial execution.