At a Glance
- Tasks: Manage clinical sites, ensure compliance, and support study recruitment.
- Company: Leading clinical research organisation with a focus on innovation.
- Benefits: Competitive salary, flexible hours, and opportunities for professional growth.
- Other info: Fast-paced environment with a strong emphasis on teamwork and development.
- Why this job: Join a dynamic team and contribute to groundbreaking medical research.
- Qualifications: Bachelor's degree in a relevant field and 8+ years of CRA experience.
Responsibilities
- Site management
- Study site selection, initiation (SIV) and clinical monitoring.
- Perform pre-study visit to ensure eligible sites are selected according to sponsor site selection criteria, including but not limited to adequate resources and experience.
- Prepare and conduct SIV to ensure adequate study training for relevant site staff to proceed with study start and conduct in compliance with protocol and relevant regulations.
- Ensure Principal Investigator/study staff complies with safety reporting requirements, as defined in protocol, SOP, ICH-GCP and GCP.
- Track study recruitment to ensure recruitment target is achieved in all studies.
- Conduct monitoring visit according to SDV plan and SOP; address issues with sites and complete monitoring visit report in a timely manner coordinating.
- Ensure timely coordination of study materials (drug, non-drug, equipments, CRFs) to the site for start-up and throughout the study.
- Assemble site specific EC submission dossier, and ensure submission to EC.
- Training
- Provide ongoing training to site staff with regards to ICH-GCP, GCP, study protocol and requirements.
- Conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements.
- Documentation
- Ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. Maintain and update these documents in investigator files, trial master files.
- Prepare/complete study records’ archiving according to protocol and sponsor requirements.
- Drug Safety
- Ensure safety information is disseminated to all sites according SOP and applicable regulations.
- Ensure SAE is reported within the timeline in compliance with SOPs and applicable regulations.
- Finance and Administration
- Finalize budget and obtain signed contract from site, prior to site initiation visit.
- Ensure Study Payment Schedule is executed and retain relevant documents/receipts.
- Study Tools and system
- Update and maintain Study tools/systems in a timely manner.
Qualifications
- Bachelor degree or above in Medical, Pharmacology or Biology related major.
- At least 8 years 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.
Contractor CRA_UK in Shrewsbury employer: Tigermed
As a Contractor CRA in the UK, you will join a dynamic team that prioritises professional development and fosters a collaborative work culture. Our commitment to employee growth is reflected in our comprehensive training programmes and supportive environment, ensuring you have the resources needed to excel in your role. With a focus on meaningful contributions to clinical research, we offer a unique opportunity to make a real impact while enjoying the benefits of a flexible work-life balance.
We think you need these skills to ace Contractor CRA_UK in Shrewsbury
Site Management
Clinical Monitoring
Study Site Selection
Safety Reporting Compliance
Recruitment Tracking
Monitoring Visit Coordination
Essential Document Collection
