Global Clinical Trial Specialist - Malaysia

Emerald Clinical Trials Inc.; Selangor; On-site; MYR 60,000 - 100,000; Full time

Benefits offered by this job

Competitive pay

Career growth

Wellbeing programs

Global opportunities

Job summary

Emerald Clinical Trials is seeking a Clinical Trial Specialist (CTS) to join the Clinical Operations team. The CTS will support clinical trial activities as the in-house site start-up and maintenance expert, ensuring trials are conducted in line with Federal Regulations, ICH guidelines, project plans, IRB/IEC requirements, and applicable SOPs.

You will coordinate essential documents for site initiation, submissions to central IRBs/IEC, and assist with local IRB/IEC submissions and ICF changes.

Qualifications

• College / University diploma / degree (or equivalent)
• Ability to perform general administrative duties as needed
• Exposure to medical terminology preferred
• Knowledge of ICH/GCP, ethical and regulatory requirements preferred

Responsibilities

• Increase proficiency in TMF set-up and maintenance (filing) for hard copy and electronic files
• Upload and maintain TMF files in Emerald Clinical’s file-sharing system by project
• Serve as second reviewer for TMF QC
• May function in TMF Lead Role and oversee TMF setup, maintenance and oversight
• Assist with end of study TMF filing (including site close out documents), QC and archival
• Develop skills in audit responses
• Perform QC of documents and emails prior to distribution
• Develop data entry skills for Clinical Trial Management System by project
• Assist with data entry support and tracking for investigator payments
• Work with CRA/CTM/PM during site start-up for feasibility
• Assist with presenting final feasibility results to PM team
• Assist sites in preparing essential document packets (EDPs)
• Submit final EDPs to sponsor or CTM/PM as required

Skills

TMF management

IRB submissions

Documentation control

QA/QC

Regulatory knowledge

Education

College / University diploma / degree

Job description

Emerald Clinical Trials is seeking a Clinical Trial Specialist (CTS) to join the Clinical Operations team. The CTS will support clinical trial activities as the in-house site start-up and maintenance expert, ensuring trials are conducted in line with Federal Regulations, ICH guidelines, project plans, IRB/IEC requirements, and applicable SOPs.

You will coordinate essential documents for site initiation, submissions to central IRBs/IEC, and assist with local IRB/IEC submissions and ICF changes.