Senior Clinical Research Associate – UK (CRA)

Tigermed; Hemel Hempstead; On-site; GBP 42,000 - 65,000; Full time

Job summary

Tigermed is seeking an experienced Clinical Research Associate to oversee site management, initiation, monitoring and safety reporting across studies. You will train site staff, ensure protocol compliance, and manage study materials and documentation with a focus on quality and regulatory adherence.

The role requires a minimum 8 years of CRA experience, strong GCP knowledge and proficiency with MS Word/Excel/PPT/Outlook, and it is based on-site at our Hemel Hempstead site.

Qualifications

• Bachelor degree or above in Medical, Pharmacology or Biology related major.
• At least 8 year of CRA experience.
• Good understanding of Good Clinical Practice and trial operation processes.
• Proficiency with Microsoft Office tools (Word, Excel, PPT, Outlook).

Responsibilities

• Site selection, initiation (SIV) and clinical monitoring.
• Perform pre-study visit to ensure eligible sites meet criteria.
• Prepare and conduct SIV to train site staff per protocol and regulations.
• Ensure PI and staff comply with safety reporting per protocol and ICH-GCP.
• Track study recruitment to achieve targets across studies.
• Conduct monitoring visits per SDV plan and address site issues.
• Coordinate timely distribution of study materials to sites.
• Assemble site-specific EC submission dossiers and submit to EC.
• Provide ongoing training to site staff on ICH-GCP, protocol and requirements.
• Maintain essential documents in investigator files and trial master files.
• Prepare study records archiving per sponsor requirements.
• Disseminate safety information to sites and report SAEs promptly.
• Finalize budgets and obtain contracts before site initiation visits.
• Update and maintain study tools and systems.

Skills

GCP knowledge

Documentation skills

Education

Bachelor degree in Medical/Pharmacology/Biology

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

Tigermed is seeking an experienced Clinical Research Associate to oversee site management, initiation, monitoring and safety reporting across studies. You will train site staff, ensure protocol compliance, and manage study materials and documentation with a focus on quality and regulatory adherence.

The role requires a minimum 8 years of CRA experience, strong GCP knowledge and proficiency with MS Word/Excel/PPT/Outlook, and it is based on-site at our Hemel Hempstead site.