Contractor CRA_UK

Tigermed; Normanton on Trent; Vor Ort; GBP 50.000 - 70.000; Vollzeit

Zusammenfassung

Tigermed is seeking a seasoned Clinical Research Associate in the United Kingdom to oversee site management, training, and documentation across studies. The role ensures compliance with ICH-GCP and regulatory requirements while coordinating study materials and EC submissions.

The ideal candidate has a bachelor degree or higher in medical/biology fields, at least 8 years of CRA experience, and strong MS Office skills.

Qualifikationen

• 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.

Aufgaben

• Site management: Study site selection, initiation (SIV) and clinical monitoring.
• Perform pre-study visit to ensure eligible sites are selected according to sponsor criteria.
• Prepare and conduct SIV to ensure training for site staff.
• Ensure PI/staff complies with safety reporting requirements.
• Track study recruitment to achieve targets.
• Conduct monitoring visits per SDV plan and SOP.
• Coordinate timely study materials to sites.
• Assemble site-specific EC submission dossier and submit to EC.
• Training: Provide ongoing training to site staff on ICH-GCP, GCP, protocol.
• Conduct site initiation to ensure thorough understanding of protocol.
• Documentation: Collect essential documents and maintain trial master files.
• Prepare/complete study records archiving.
• Drug Safety: Disseminate safety information to sites and report SAE promptly.
• Finance and Administration: Finalize budget and contracts; manage study payments.
• Study Tools and System: Update and maintain study tools/systems.

Ausbildung

8 years CRA experience

GCP knowledge

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Jobbeschreibung

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.