Clinical Trial Administrator

Key Requirements

• Bachelor's degree in Healthcare, Life Sciences, or a related field preferred.
• 2+ years of experience as a Clinical Trials Administrator within a CRO/clinical research environment.
• Good understanding of ICH-GCP, medical terminology, and regulatory requirements.
• Experience supporting Phase I–IV clinical trials of normal to medium complexity.
• Proficiency in MS Word, Excel, PowerPoint, and Outlook.
• Strong communication, organisation, problem-solving, and analytical skills.
• Ability to manage multiple priorities, meet deadlines, and work independently and collaboratively.
• Fluent in written and spoken English.

Key Responsibilities

• Provide administrative and operational support to CRAs, LCRAs, and Project Managers throughout clinical studies.
• Prepare, review, maintain, and distribute study documents, trackers, templates, and reports.
• Maintain TMF/ISF, CTMS, databases, and study tracking systems, ensuring documents are complete and audit-ready.
• Support study meetings, kick-off meetings, training, presentations, scheduling, and travel arrangements.
• Track action items, decisions, issues, training records, and study timelines.
• Support site selection, site initiation, monitoring visits, protocol amendments, and study supplies.
• Assist with regulatory/REC/IRB documentation and tracking of required approvals.
• Coordinate with CRAs, PMs, study teams, vendors, sites, and clients to ensure timely communication and study delivery.
• Perform TMF/ISF quality checks, reconciliation, audit preparation, and archiving.
• Ensure compliance with ICH-GCP, GxP, applicable regulations, and company SOPs.
• Support process improvements, departmental initiatives, and other ad hoc project activities.