Job Description:

1) Feasibility studies and enquiries

• Conduct and prepare report to Sponsor in a timely manner.

2) Documents development

• Assist in developing and writing trial protocols, case report forms, patient information sheet, patient diary, randomization schedule and any other required documents for specific study.
• Perform literature search.

3) Communication

• Communicate effectively with Sponsor / Investigator and team to ensure timely progress of each process in the preparation and conduct of each study.
• Ensure communication process is maintain in accordance to each study.

4) Ethics and Regulatory Submission and Approval

• Ensure accuracy and timeliness in the respective submission process.
• Liaise and follow-up closely with ethics and regulatory authority on any outstanding / pending issues until approval letter from ethics and regulatory are received.
• Update Reporting Head / Sponsor and required parties on issues / amendments / approvals in an efficient and timely manner.

5) Conduct of Studies

• Attend all required meetings / discussion / training, internal and external.
• Ensure assigned tasks are carried out with accuracy, timeliness, efficiently and completeness.
• Ensure all reports are prepared and submitted in a timely manner.
• Ensure all sites tasks are carried out and completed in each visit and to report any untoward delays immediately to the Project Manager.

6) Maintenance of Database

• Develop and improve required databases: Investigator / Industry & Feasibility.

7) Technical Support, Development & Training

• Develop, maintain, and implement controlled documents processes and SOPs.
• Prepare documentations, and team for internal and external audit and for application of certifications and accreditations.
• Provide technical support to Quality Division.
• Remain informed and current on local and international industry standards / guidelines / laws.
• Liaise with Quality and other divisions as required.
• Work as part of the team and on own in a constructive manner.
• Conduct training in research development program organized by company.
• Promote safe working environment.

Qualification / Job Requirements:

• Bachelor’s Degree in biotechnology, life science, or any related field.
• Has a strong interest in clinical research as a career path.