IRT Project Coordinator
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
In this role, you will have the opportunity to provide support to the lead IRT project manager in the documenting, training, and deploying of IRT applications.
This is a unique opportunity for someone looking to start their career in the clinical research industry. We are looking for someone with strong administrative skills with great customer service. The role is ideal for someone technically minded with a desire to move into a IRT Project Manager role in the longer term.
You’ll be accountable for:
- Working with the IRT project manager and client to develop user guides, worksheets, and other IRT related documentation
- Maintaining relevant eTMF documentation and IRT validation documentation (hard copy and electronic)
- Requesting, receiving and logging draft subject and material randomization schedules as per SOP as well as signatures for all final and approved IRT documentation and Inventory Release Files (IRFs)
- Developing IRT presentations and materials for use at Investigator Meetings
- Assisting with the authoring of Drug Supply Procedures and protocol specific support guidelines
- Conducting User Acceptance Testing (UAT)
- Assisting with the release of IRT systems and the conduct of Production Quality Control Tests
- Taking meeting minutes
- Minimum of a High School diploma. University education is preferred
- 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
- Ability to work with a sense of urgency