Contractor CRA_UK

Tigermed; Wollaton; On-site; GBP 65,000 - 90,000; Full time

Job summary

Tigermed is seeking an experienced CRA to oversee site management, training, documentation, safety reporting, finance, and tool maintenance across multiple studies. The role requires in-depth knowledge of ICH-GCP and clinical trial operations, with 8+ years of CRA experience and strong MS Office skills.

Responsibilities include SIV, site initiation, monitoring, and ensuring compliance, safety reporting, budget finalisation, and timely study materials coordination.

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.
• Strong skills in MS Word, Excel, PPT and Outlook.

Responsibilities

• Site management including site selection, initiation (SIV) and clinical monitoring.
• Provide ongoing training to site staff on ICH-GCP, protocol and study requirements.
• Maintain essential documents and trial master files, and ensure archiving.
• Disseminate safety information and report SAEs within SOP timelines.
• Finalise budgets and manage study payment schedules with sites.
• Update and maintain study tools and systems in a timely manner.

Skills

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Outlook

Education

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

Job description

Responsibilities

(a) 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.

(b) 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.

(c) 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.

(d) Study Tools and system

• Update and maintain Study tools/systems in a timely manner.

3. Qualifications

1. 3.1 Bachelor degree or above in Medical, Pharmacology or Biology related major.
2. 3.2 At least 8 year of CRA experience;
3. 3.3 Good understanding and knowledge of Good Clinical Practice and clinical trial operation processes/procedures;
4. 3.4 Good skills on Microsoft Word, Excel, PPT and Outlook, etc.