Senior Clinical Trials Associate
- Virtual, Home Office, United States
- Employees can work remotely
- Department: Clinical Operations
We are currently developing voclosporin, an investigational therapy, for the treatment of lupus nephritis (LN) and other proteinuric diseases. We are also advancing voclosporin ophthalmic solution (VOS), a topical formulation, for the treatment of dry eye syndrome (DES). And we are actively hunting for other innovative drugs which have the potential to change the lives of people with rare autoimmune and inflammatory diseases.
The Senior Clinical Trials Associate (Senior Associate, Clinical Operations) is responsible for supporting and assisting the clinical study teams in the execution of all clinical trials being conducted by Aurinia Pharmaceuticals Inc. They 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 project 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
- Accountable for management and oversight of clinical trial master files (TMF) from set up through archive. Direct and conduct file reviews and QC checks for completeness and accuracy of essential documents, including development of related TMF 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-IMP).
- Assist with tracking and verification of study and site-specific payments
- 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
- 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. Senior Associate level incorporates all of the above, including:
- Providing support for multiple or global level studies
- Developing and maintaining appropriate tracking tools for trial related metrics
- Independently managing / overseeing TMF activities on global level including vendor management
- Assisting with and support global budget tracking and reporting activities
- Liasing with cross functional departments including but not limited to: Finance, Regulatory, Medical Affairs to support clinical trial activities as required
- Assisting and supporting clinical supplies management (IMP)
- Bachelors 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 with Microsoft Office Products—Word, Excel, PowerPoint, SharePoint (preferred).
- Proficiency with filing systems and organizational tools.
- Ability to work effectively in cross-functional teams.
- Ability 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, a desire to support the team to succeed in improving the lives of patients.
All candidate information will be kept confidential according to EEO guidelines.