Senior Clinical Research Associate - Site & Start-Up Lead

Tigermed; Hawton; On-site; GBP 42,000 - 68,000; Full time

Job summary

Tigermed is seeking an experienced Clinical Research Associate (CRA) to manage clinical site activities in the United Kingdom, including site selection, initiation, and monitoring to ensure protocol compliance.

You will train site staff on ICH-GCP and study requirements, oversee safety reporting, and coordinate study materials, budgets, and payments. Strong documentation and SOP adherence are essential.

Qualifications

• Bachelor degree or above in Medical, Pharmacology or Biology related major.
• At least 8 year of CRA experience.
• Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures.
• Good skills on Microsoft Word, Excel, PPT and Outlook, etc.

Responsibilities

• Site management including study site selection, initiation (SIV) and clinical monitoring.
• Perform pre-study visits to ensure eligible sites are selected according to criteria.
• Prepare and conduct SIV to train site staff for study start and conduct.
• Ensure PI/study staff complies with safety reporting requirements as per protocol and regulations.
• Track study recruitment to achieve targets across studies.
• Conduct monitoring visits per SDV plan and SOP; address site issues and complete reports.
• Coordinate timely delivery of study materials to sites for start-up and throughout the study.
• Assemble site-specific EC submission dossier and ensure submission to EC.
• Provide ongoing training to site staff on ICH-GCP, GCP, protocol and requirements.
• Conduct site initiation to ensure understanding of protocol and requirements.
• Collect essential documents timely and maintain investigator files and trial master files.
• Prepare/complete study records archiving as per protocol and sponsor requirements.
• Disseminate safety information to sites and report SAEs within timelines.
• Finalize budgets and obtain signed contracts prior to site initiation visit.
• Ensure Study Payment Schedule is executed and retain receipts.
• Update and maintain Study tools/systems timely.

Skills

CRA experience

GCP knowledge

MS Word/Excel/PPT/Outlook

Education

Bachelor degree or above in Medical, Pharmacology or Biology related major

Tools

Microsoft Word

Microsoft Excel

PowerPoint (PPT)

Outlook

Job description

Tigermed is seeking an experienced Clinical Research Associate (CRA) to manage clinical site activities in the United Kingdom, including site selection, initiation, and monitoring to ensure protocol compliance.

You will train site staff on ICH-GCP and study requirements, oversee safety reporting, and coordinate study materials, budgets, and payments. Strong documentation and SOP adherence are essential.