Clinical Research Associate

Role overview

This role is centered on managing clinical study sites from the selection stage through initiation, active monitoring, and final close-out. The Clinical Research Associate will ensure work is carried out in line with Tigermed or sponsor SOPs, ICH-GCP, GCP, and all other relevant regulations. A key part of the job is making sure data from assigned sites is accurate, delivered on time, and kept within the approved budget.

What you will do

• Handle study site selection, site initiation visits, and ongoing clinical monitoring for assigned studies.
• Carry out pre-study visits to confirm that selected sites meet sponsor criteria, including sufficient resources and relevant experience.
• Plan and deliver site initiation visits so site teams receive the training needed to begin and run the study in compliance with the protocol and regulations.
• Make sure the principal investigator and study staff follow safety reporting obligations set out in the protocol, SOPs, ICH-GCP, and GCP.
• Monitor study recruitment progress and take action to help sites meet enrollment targets.
• Conduct monitoring visits based on the source data verification plan and SOPs, resolve site issues, and submit visit reports promptly.
• Coordinate the timely delivery of study materials such as drugs, non-drug supplies, equipment, and CRFs to sites throughout start-up and the full study period.
• Prepare site-specific ethics committee submission documents and ensure they are submitted correctly.
• Provide continuous training to site personnel on ICH-GCP, GCP, protocol requirements, and study-specific procedures.
• Ensure essential documents are collected, maintained, and updated properly in investigator files and trial master files from start-up through close-down.
• Prepare archiving records for study documents in line with protocol and sponsor expectations.
• Support drug safety processes by sharing safety information with all sites according to SOPs and applicable rules.
• Ensure serious adverse events are reported within required timelines and in compliance with regulations.
• Complete budget finalization and obtain the signed site contract before the initiation visit.
• Make sure the study payment schedule is carried out and that all supporting documents and receipts are retained.
• Keep study tools and systems updated and maintained without delay.

Requirements

• Bachelor’s degree or higher in Medicine, Pharmacology, Biology, or a related discipline.
• 1 to 3 years of clinical research associate experience.
• Strong working knowledge of Good Clinical Practice and clinical trial operations.
• Comfortable using Microsoft Word, Excel, PowerPoint, and Outlook.
• Strong candidates may be considered even if they do not fully match the stated background requirements.

Additional information

This position requires project management and site management ownership across the study lifecycle, with attention to compliance, quality, timelines, and budget control. The role also includes coordination of safety reporting, financial administration, document control, and study system maintenance.

Compensation

No salary or stipend amount was specified for this role.