About the Role:

We are looking for highly driven individual to be part of our team as Clinical Research Associate to execute clinical research to support quantitative and qualitative data collection as well as clinical coordination between all stakeholders. The candidate will have the opportunity to be at the frontline of clinical research for cell therapy. The CRA will be involved in planning, developing and overseeing the day-to-day clinical activities for specified clinical research initiatives in accordance with the research parameters established by the Company. The CRA will also assist in developing budgets and operating procedures for the project, coordinating day-to-day administration related to interaction with associated departments, agencies and vendors.

Job Responsibilities:

• Plan, schedule and carry out day-to-day related procedures, ensuring efficient workflow, including but not limited to: recruiting patients into our studies, obtaining written consent from patients, administering surveys to patients (data collection) and preparation of all study related paperwork;
• Ensure all clinical activities are carried out in accordance with established research protocol and standards and in compliance with all applicable laws, regulations, policies and procedural requirements;
• Manage data entry and prepare reports and execute various data collection tools;
• Serve as a primary point of liaison between clinical investigators, ancillary departments, regulatory bodies, participants and Company;
• Keep updated and advise on regulatory update and requirements;
• Undertake case note reviews;
• Handle collection of materials and delivery of products from manufacturing site to clinical site and other needed locations;
• Keep track and manage inventory of materials needed for clinical study and activities;
• Manage cost of study and clinical activities;
• Set up and manage research meetings;
• Manage and coordinate with all stakeholders, including local partners in Singapore and Malaysia; and
• Assist in all other tasks assigned from time to time.

Location: Johor Bahru, Johor