Project Specialist

About the role

Project Specialist at WEP Clinical is a focused operational role dedicated to the success of Expanded Access Programs. In this capacity, you will own the end-to-end administration and logistical execution of projects designed to increase patient access to investigational therapies. Your daily work will directly influence the successful delivery of programs that address critical unmet medical needs. You will serve as a central operational hub, balancing procedural diligence with proactive problem-solving to ensure seamless program execution. Success in this position requires meticulous attention to detail and the ability to act as a key liaison, ensuring all project elements align precisely with client specifications and regulatory demands. This role is integral to maintaining the integrity and efficiency of vital access initiatives.

Key facts

What you'll do

• Perform intake verification and validate initial submission details for new EAP requests to establish a solid project foundation.
• Design and implement robust filing structures within electronic trial master file platforms to support efficient tracking and retrieval of project data.
• Review all protocol versions and associated documentation to confirm correctness prior to any external distribution, thereby preventing potential errors.
• Prepare and ship final project components to clients, ensuring all materials are accurate and compliant with established standards.
• Enforce strict timeline adherence throughout the distribution process, proactively managing deadlines to meet project milestones.
• Establish partner checkpoints to clarify objectives and delineate roles for all stakeholders involved in the project lifecycle.
• Maintain precise records inside clinical trial management systems, ensuring all project status updates are current and visible to internal and external parties.
• Verify regulatory and internal compliance during every project phase, monitoring these elements continuously to mitigate potential risk.
• Facilitate cross-functional communication, translating complex requirements into clear, actionable outcomes for diverse teams.
• Act as a central resource for EAP activities, coordinating the end-to-end workflow and providing operational support as needed.

Requirements

Candidates must bring a minimum of three years of prior project coordination experience to this role. A background in clinical research operations is considered highly valuable for success in this environment. You must possess hands-on experience with electronic trial master file systems to perform essential duties. Familiarity with clinical trial management systems is required to navigate the operational landscape effectively. The ability to manage tasks with strict deadlines is non-negotiable for this position. You must thrive in environments demanding detailed documentation and precision in all outputs. Clear communication skills are necessary to convey information effectively in written and verbal formats. Your audience will include clients, regulators, and internal team members, requiring adaptability in all interactions. The capacity to adjust communication style for diverse groups is mandatory to ensure understanding and alignment. A commitment to maintaining the highest standards of accuracy and compliance is essential for this vital operational role.

Nice to have

There are no preferred items listed for this role beyond the core qualifications.

Practical notes

This is a full-time position based in Morrisville, North Carolina, United States. The offered compensation is $64,000.00 on an annual basis, with benefits eligibility potentially applying after the individual meets standard company criteria. Please confirm the remote policy, pay details, and exact start date by reviewing the official apply page before proceeding with your application. Ensure that your application materials are current and complete, specifically tailored to highlight your relevant experience in project coordination. Demonstrate how your past professional history aligns with the demanding requirements of this vital operational position within the Expanded Access Programs framework.

It is essential to review the official source material to ensure you have the most up-to-date information regarding responsibilities, compensation, and logistical details. This step ensures that your application is aligned with the specific expectations outlined by WEP Clinical. Verifying these details directly prevents any potential misalignment between your expectations and the role requirements. Taking the time to review the official page demonstrates a serious commitment to the application process and ensures you are fully informed.