IRT Project Coordinator

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Job description

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We're looking for an exceptional IRT Project Coordinator to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

Role Responsibilities:

• Liaises with assigned IRT Project Manager to develop study documentation including but not limited to user guides, presentations, and data change forms.
• Maintains relevant IRT documentation in eTMF as necessary.
• Maintains study IRT document repository including validation documentation.
• Ensures a state of audit readiness in collaboration with IRT Project Manager.
• Ensures compliance with the completion of all project tasks.
• Requests, obtains, and logs signatures for all final and approved IRT documentation.
• Request, receive, and log Inventory Release Files (IRFs).
• Assists with the conduct of User Acceptance Testing (UAT).
• Other tasks as assigned.

You'll Need:

• Minimum of a High School diploma or G.E.D
• Experience with Microsoft Office products including MS Word, MS Excel, and Access.
• Excellent communication skills (interpersonal, written, verbal) and the ability to communicate highly technical information to all stakeholders.
• Ability to prioritize and manage tasks in a fast-paced mission critical environment.

At Premier Research, we are science-minded and heart-centered. Join us.