- Remote, Home Office, United States
- Department: Clinical Operations
Aurinia exists to make a difference in transforming people’s lives by delivering innovative treatments to patients living with serious, rare autoimmune and inflammatory diseases. From the earliest days of the company, we’ve applied an inventive, thoughtful, and responsible approach to developing therapies for people in need. Through our dedication, we relentlessly preserve and execute with integrity to reach our main objective, to improve patients’ health.
In addition to driving adoption of our approved therapy, LUPKYNIS™, for appropriate people with lupus nephritis, we are also actively pursuing a broader portfolio of innovative drugs for autoimmune disease.
Our strategy leverages the skills and knowledge of our incredible team and our deep experience in principled drug development and commercialization. Aurinia provides a working environment where individuals can thrive in a professional, creative, and inspirational atmosphere. Together, we are driven to make an impact for our patient communities as advocates and partners in innovation.
The Document Coordinator contributes to the management and support of the Trial Master File (TMF), including start-up activities, document review and quality control (QC), ongoing quality and completeness reviews, and close-out activities. This individual works with the internal study team on TMF activities to ensure quality deliverables.
- Review documents submitted to eTMF for suitability.
- Generate TMF related findings and see through to resolution.
- Review the TMF for completeness.
- Resolve TMF findings related to audits, completeness reviews, and/or inspections.
- Assist with the creation and revision of study specific TMF Plans and Maps.
- Support Aurinia functional groups to ensure overall TMF completeness.
- Maintain expected TMF metrics for assigned job functions (e.g., document processing)
- Ensure work is performed in compliance with GCP requirements.
- Other such duties as may be determined or assigned.
- Minimum of 2 years of experience managing TMF activities to support clinical studies.
- Bachelor’s degree preferred.
- Experience in managing paper and electronic TMFs.
- Experience with DIA TMF Reference Model.
- Knowledge of the drug development process and GCP requirements.
- Working knowledge of international regulatory record requirements and ethics requirements.
- Experience in managing TMF documents during regulatory inspections is an asset.
- Strong computer skills including Outlook, MS PowerPoint, MSWord and MS Excel.
- Ability to work well independently as well as a member of multiple, collaborative, integrated teams.
- Excellent organizational and time management skills.
- Ability to multi-task and manage several projects in parallel while paying attention to detail.
- Strong critical thinking skills and ability to contribute creative yet practical solutions to problems.
- Ability to travel (including internationally) when possible, and to work across cultures
All candidate information will be kept confidential according to EEO guidelines