Senior Clinical Trial Associate
- 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 Senior Clinical Trial Associate (Sr. CTA), is responsible for supporting and assisting the clinical study teams in the execution of all clinical trials being conducted by Aurinia Pharmaceuticals Inc. S/he will be responsible for managing start-up activities, study documentation, 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).
- Provide operational support to the clinical trial/project managers and other clinical project team members for multiple and/or global studies, 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.
- Contribute to 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.
- Contribute to clinical trial master files (TMF) from set up through archive. Conduct file reviews and QC checks for completeness and accuracy of essential documents, including development of related TMF processes. Ensure complete and accurate upload of documents as per study specific plans.
- 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-IMP).
- Assist with and support tracking and verification of global study and site-specific payments and other reporting activities.
- Develop and maintain tracking systems and tools and report study metrics for trial related metrics.
- Coordinate meetings/telecons/ Web/Ex.
- Prepare agendas, minutes, and track action items and collaborate/follow up with study team members as required.
- Oversee and manage updates, additions and revisions to clinicaltrials.gov to meet regulatory requirements.
- Manage the development and formatting of departmental documents, presentations, and project-specific plans.
- Participate in review/QC checks of clinical trial data as needed.
- Liaise with cross functional departments including but not limited to: Finance, Regulatory, Medical Affairs to support clinical trial activities as required.
- Bachelor’s degree or equivalent with minimum 3-5 years clinical trial experience within the pharmaceutical or biotechnology industry.
- Basic understanding of the drug development process and clinical trial execution.
- Good knowledge and understanding of GCP/ICH required.
- Experience managing and overseeing (e)TMF systems and knowledge of essential clinical documents.
- Proficiency Microsoft Office Products—Word, Excel, PowerPoint, SharePoint (preferred).
- Proficiency with filing systems and organizational tools.
- Works effectively in cross-functional terms.
- Able to interact professionally and productively and effectively influence others.
- Displays strong organization and time management skills; reliable in completing tasks and delivering on commitments in a timely manner.
- Excellent attention to detail.
- High ethical standards and integrity.
All candidate information will be kept confidential according to EEO guidelines