Job Title: Clinical Research Associate II (CRA II)
Location: Malaysia (Various Sites)
Job Type: Full-Time
Travel Requirement: Approximately 60% (domestic and international)
Role Overview:
We are seeking an experienced Clinical Research Associate II to support our global clinical trials. This role is responsible for ensuring clinical trial sites adhere to study protocols, regulatory standards, and quality guidelines. The CRA II will conduct regular site visits, support clinical trial activities, and help maintain data integrity across the trial's lifecycle.
Primary Responsibilities:
- Site Monitoring: Conduct site qualification, initiation, monitoring, and close-out visits, ensuring all procedures comply with industry SOPs and global clinical standards.
- Data Quality and Compliance: Oversee data integrity and patient safety throughout trials, addressing any protocol or regulatory compliance issues.
- Investigator Collaboration: Coordinate with investigators and site staff to facilitate smooth study operations and support patient recruitment targets.
- Documentation and Quality Control: Maintain complete records and ensure all data meets quality and regulatory standards.
- Drug Accountability: Oversee site-level drug storage and usage, ensuring compliance with study guidelines.
- Mentorship and Support: Provide guidance to less-experienced colleagues and participate in feasibility assessments for upcoming projects.
- Project Coordination: Communicate with project managers on site status and study progress.
Candidate Requirements:
- Education: Bachelor's degree in a life sciences or healthcare field.
- Experience: Minimum of 2 years as a Clinical Research Associate in a regulated environment.
- Skills: Strong organizational and communication skills, with the ability to work both independently and in a team. Familiarity with clinical data systems and industry regulations.
- Technical Proficiency: Comfortable with data systems and monitoring software used in clinical trials.
Additional Information:
- Regular travel required (approximately 60% domestic and international).
- Commitment to high standards of quality, safety, and continuous improvement.