Expanded Access Programs Coordinator

WEP Clinical Inc.; United Kingdom; On-site; GBP 30,000 - 42,000; Full time

Benefits offered by this job

Group Private Medical Insurance

Group General Life Assurance

Group Critical Illness and Group Incom

Job summary

WEP Clinical is seeking a proactive Project Specialist to support the setup, implementation, and management of Expanded Access Programs (EAPs). You will maintain trial master files, support CTMS, and help the team meet client expectations.

In this role you will collaborate with project management, supply chain, and finance to run projects efficiently, ensure regulatory compliance (FDA/GCP/ICH), and organize study materials and data across systems.

Qualifications

• Bachelor’s degree in a health or science field
• 1–3 years’ experience in project management or clinical research
• Effective verbal and written communication skills
• Computer literacy and proficiency in Microsoft Office
• Ability to handle confidential information with discretion
• Strong organizational skills and attention to detail

Responsibilities

• Assist with the development and execution of Expanded Access Programs (EAPs).
• Collaborate with the project management team to ensure projects meet client expectations.
• Coordinate and dispatch shipments of investigational products according to SOPs.
• Support filing of vendor invoices for EAPs with the project and finance teams.
• Maintain sponsor and site contact lists.
• Communicate with sites for EAP enrollment and maintenance as needed.
• Organize and maintain program-level documents within OneDrive or SharePoint.
• Assist with collection and review of study documents to meet FDA/GCP/ICH requirements.
• Prepare Investigational Product Review Forms (IPRFs) and submit to Regulatory team.
• Support study file preparation including eTMF maintenance.
• Enter and maintain program, site, and patient-level data in CTMS.

Skills

Team Player

Adaptable

Detail Oriented

Problem Solver

Education

Bachelor's degree in health or science

Tools

Microsoft Office

Job description

WEP Clinical is seeking a proactive Project Specialist to support the setup, implementation, and management of Expanded Access Programs (EAPs). You will maintain trial master files, support CTMS, and help the team meet client expectations.

In this role you will collaborate with project management, supply chain, and finance to run projects efficiently, ensure regulatory compliance (FDA/GCP/ICH), and organize study materials and data across systems.