Clinical Trial Associate
Reporting Line: Senior VP, Global Clinical Operations
Location: Seattle, WA (home-based)
Purpose of Position
The Clinical Trial Associate (CTA) is responsible for supporting and assisting the clinical study teams in the execution of all clinical trials being conducted by Aurinia Pharmaceuticals Inc. The CTA may be responsible for managing startup activities, vendor communication or other project activities as assigned to ensure efficient execution of trials within established budgets and timelines, while ensuring all activities occur in compliance with the appropriate regulations and guidelines including ICH/GCP and relevant Standard operating procedures (SOPs).
Roles & Responsibilities:
- Provide operational support to the clinical program managers and other clinical project team members, such as; review clinical project invoices for relevance and accuracy and track study budgets, initiate and track contract documents, communicate with CROs, vendors, and clinical trial sites, draft project team meeting agendas and minutes, ensure team access to vendor websites and portals, etc.
- Participate in the development of project-specific processes, and protocol-specific reference materials.
- Initiate and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training materials, study binders, plans, study registration and other process descriptions, presentations, newsletters and reports.
- Supervise the management or oversight of clinical trial master files from set up through archive, and direct and conduct file audits for completeness and accuracy of essential documents, including development of related processes.
- Supervise the electronic filing and maintenance of clinical project documents on the Clinical Operations network drive, including development of related processes.
- Supervise the inventory, tracking, and shipment of clinical trial supplies (non-IP).
- Assist with tracking and verification of study and site-specific payments.
- Set up and maintain tracking systems and tools and report study metrics to support the clinical study.
- Coordinate meetings/telecons/ Web/Ex. Prepare agendas, minutes, and track action items.
- Supervise additions and revisions to clinicaltrials.gov to meet regulatory requirements.
- Manage the development and formatting of departmental documents, presentations, and project-specific plans.
Bachelor’s degree or equivalent with minimum 2 years clinical trial experience within the pharmaceutical or biotechnology industry
Basic knowledge and understanding of GCP/ICH required
Proficiency Microsoft Office Products—Word, Excel, PowerPoint, SharePoint (preferred)
Proficiency with filing systems and organizational tools
Able to multi-task under limited direction and on own initiative
Ability to contribute creative yet practical solutions to problems
Strong communication and inter-personal skills
Able to recommend and implement process improvements
Highly responsive and proactive, a team player
Ability to travel (including internationally) and work across cultures
Please fill out the form below to submit your application.