Full-Time Senior Clinical Research Associate

We're seeking a knowledgeable and team-oriented Senior CRA to manage clinical aspects of full-service global projects in Malaysia.

As a Senior CRA at PSI, you'll be at the forefront of communication with project stakeholders, ensuring successful clinical trial conduct across various therapeutic areas.

Responsibilities Include:

1. Supervise study activities, timelines, milestones, and schedules on the country level.
2. Conduct and report all types of onsite monitoring visits.
3. Be involved in study setup, including site contract and budget negotiations.
4. Manage site communication and ensure consistency of study processes.
5. Identify country-specific differences and oversee tracking systems.
6. Contribute to project planning documents and instructions.
7. Act as a point of contact for in-house support, contractors, global teams, and vendors.
8. Execute and oversee clinical trial country submissions and approvals.
9. Develop local language materials (Informed Consents, translations).
10. Partner with IRB/IEC and Regulatory Authority for submission and approval processes.

Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, or Registered Nursing (or equivalent).
• Registered Pharmacist preferred.
• 4-5+ years of demonstrable, independent on-site monitoring experience.
• Extensive Phase II and/or III clinical trial monitoring experience.
• Proficiency in feasibility assessment and study setup processes is desirable.
• Oncology/Hematology experience is a plus.
• Strong planning, multitasking, and teamwork skills.
• Excellent communication, collaboration, and problem-solving skills.
• Willingness and ability to travel extensively within Malaysia.

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