Clinical Trial Associate (any level)
Faraday Pharmaceuticals, Inc., SEATTLE WA
Faraday Pharmaceuticals is a biopharmaceutical company focused on improving outcomes of critical care illnesses by reducing the loss of cardiac and skeletal muscle function. We are currently studying FDY-5301, an elemental reducing agent containing sodium iodide, which catalytically destroys the hydrogen peroxide that is naturally generated as a response to acute ischemia-reperfusion injury and contributes to loss of muscle mass and function.
The Clinical Trial Associate (CTA) will support the operational management and oversight of Faraday’s upcoming studies, including a phase 3 study in the treatment of acute ST segment elevation myocardial infarction (STEMI) and reperfusion injury and a phase 2 study in Intensive Care Unit Acquired Weakness.
While working in the offices of Faraday, the CTA is responsible for supporting the Clinical Operations team for the operational execution of quality studies from planning and start-up through study closeout. The CTA will assist with clinical trial planning and execution activities and assist in the coordination of documentation associated with the conduct of investigational clinical studies in accordance with Food and Drug Administration (FDA) Regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures.
- Supports the Clinical Operations teams in study execution
- Collaborates with Clinical Trial Managers, Clinical Research Associates, and Contract Research Organization staff to support trial monitoring and management activities
- Ensures Inspection Readiness by managing the set-up, maintenance, and quality control of the internal Trial Master Files and overseeing the CRO’s management of Trial Master Files
- Manages the Clinical Operational internal document filing system and documents
- Contributes to the preparation of trial-related materials (clinical protocols, Informed Consent Forms, Case Report Forms, Standard Operating Procedures, Monitoring Plans, Laboratory Manuals, Pharmacy Manuals, Study Reference Manuals)
- Assists in the coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages and IP release
- Assists with planning, preparation, and on-site support of investigators meetings
- BS/BA in Life Science or related discipline
- At least 1 year of clinical operations experience in the pharmaceutical industry
- Experience with essential documentation for Trial Master Files
- Knowledge of drug development, clinical operation processes and procedures according to FDA GCP/ICH regulatory guidelines
- Strong communication, organizational and interpersonal/team skills
- Strong skills with Microsoft Excel, Word and PowerPoint
- Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
- Strong attention to quality/detail