About the Role:

Neurasia Sdn Bhd is seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our team. As a CRA at our Contract Research Organisation (CRO), you will be responsible for overseeing and monitoring clinical trials to ensure they are conducted in compliance with study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements. You will plat a crucial role in ensuring the accuracy, completeness, and reliability of trial data and supporting site staff to ensure successful trial execution.

Job Descriptions:

• Conduct site visits to ensure that clinical trials are being conducted in accordance with the study protocol, Good Clinical Practice (GCP) guidelines, and regulatory requirements.
• Ensure all data collected during the trial is accurate, complete, and verifiable. They must review source documents, case report forms, and electronic data capture systems to ensure that data is consistent and reliable.
• Assist the Neurasia Sdn Bhd Project Management team in the planning, development, and execution of core study documents and associated documentation deliverables.
• Assist in the training, mentoring and support of colleagues or team members when required.
• Establish positive relationships with site staff, including investigators, study coordinators, and other personnel.
• Provide training, guidance, and support as needed to site coordinators to ensure that the trial is conducted successfully.
• Maintain complete and accurate records of all trial-related activities, including site visits, montoring reports, and correspondence with investigators and sponsors.
• Update Neurasia Sdn Bhd Project Managers and Clients on trial’s progress, including any issue or concerns that may arise. They must also provide regular updates on enrolment, data quality, and other important metrics.
• Work with drug safety team to ensure reporting is conducted in accordance with regulatory requirements. This includes monitoring adverse events and ensuring that they are reported to the appropriate authorities in a timely manner.
• Participate in study start-up activities including site selection, site-initiation visits, feasibility assessment, and regulatory submissions.

Job Requirements:

• Bachelor’s degree in Life Sciences, Nursing, or a related field.
• Proven experience as a Clinical Research Associate in the clinical research or pharmaceutical industry.
• In-depth knowledge of GCP guidelines and regulatory requirements.
• Strong understanding of clinical trial processes, including site management and monitoring.
• Excellent organisational and time management skills, with the ability to manage multiple tasks and priorities effectively.
• Strong analytical skills and attention to detail.
• Effective communication and interpersonal skills, with the ability to establish positive relationships with site staff and colleagues.
• Proficiency in using electronic data capture systems and clinical trial management software.
• Ability to work independently and as part of a team, demonstrating flexibility and adaptability in a dynamic environment.
• Willingness to travel as required for site visits and other trial-related activities.

About the Company:

Neurasia Sdn Bhd is a multinational Scientific Contract Research Organisation (CRO) dedicated to pioneering advancements in comprehensive healthcare clinical research. Located in the vibrant city of Kuala Lumpur, Malaysia, Neurasia stands at the forefront of integrating science, medicine, and entrepreneurship to propel global health initiatives forward. Our strategic positioning in Malaysia allows us to serve biopharmaceutical companies based in the USA, UK, and Australia effectively, providing them with a gateway to the Asian market while concurrently enhancing Malaysia’s stature in the international biotechnological landscape. At Neurasia, we are committed to setting global standards, fostering innovation, and ensuring that Malaysia emerges as a significant player in the biotechnology sector.