Project Specialist

The Ideal Candidate:

• Team Player
• Adaptable
• Detail Oriented
• Problem Solver

What You'll Do:

• Assist with the development and execution of EAPs.
• Work with the project management team to ensure projects are completed in accordance with client expectations.
• Work with the supply chain team to coordinate and dispatch shipments of investigational products according to the WEP Clinical SOP’s.
• Support the project team and finance team with filing vendor invoices for EAPs.
• Maintain the sponsor and site contact list.
• Communicate with sites for EAP enrollment and maintenance as needed.
• Organize and maintain shared program-level documents within internal OneDrive or SharePoint.
• Assist with project documentation collection and review from investigational sites, ensuring they meet FDA/GCP/ICH requirements.
• Prepare Investigational Product Review Forms (IPRFs) and submit to WEP Clinical Regulatory team.
• Support preparation of study files based on project scope including maintenance of internal or external document storage systems including Electronic Trial Master File (eTMF).
• Enter and maintain program, site, and patient-level data into the EAP Clinical Trial Management System (CTMS).

What You'll Need:

• Bachelor’s degree (In a health or science field preferred)
• 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 complete discretion
• Strong organizational skills and attention to detail
• Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriate