Clinical Trial Associate at Travere Therapeutics in SD Metro Area

Summary: Travere Therapeutics is a biopharmaceutical company dedicated to delivering innovation and hope to patients in the rare disease community. The Clinical Trial Associate will assist the project team in managing day-to-day operational activities of clinical studies, ensuring compliance with regulations and standard operating procedures. Responsibilities: - Familiar with FDA regulations, as well as GCP/ICH requirements - Assists the study team in all aspects of the day-to-day operational activities of clinical studies. Coordinates, tracks, and manages daily activities for multiple clinical studies to support the internal project team, vendors, stakeholders, and CROs, as applicable - Coordinates project meetings, including scheduling, preparation of meeting materials, drafting and distribution of meeting agendas and minutes - Ensure that delegated components of clinical trials are executed in accordance with specified SOP and within defined timelines - Under the guidance and direction of Clinical Operations team, the CTA interfaces with other Travere R&D functions to coordinate relevant and timely exchange of information, materials, and/or reviews to support successful trial operations and management consistent with the drug development plan - Works directly with Clinical Operations and study team to optimize and implement clinical studies according to GCPs and relevant SOPs - Receive, review, and assess study documents required for site activation and investigational product release - Maintain metrics on results of study documentation reviews and patient enrollment - Create and ship investigator site binders, as applicable - Assist with IRB submissions and IRB correspondence. Ensure all documents are added to the electronic Trial Master File (eTMF) with appropriate naming conventions per relevant SOPs - Supports internal Clinical Operations in monitoring the implementation and progress of a clinical study - Manage and update study contact lists - Supports reconciliation of vendor invoices/PO management, as well as vendor and contractor payments as applicable - Tracks study status, enrollment, EDP review, and site start‐up status for assigned clinical projects including review and approval of regulatory package for release of investigational product - Responsible for setup, maintenance, reconciliation, transfer (if applicable), and archiving the eTMF along with internal working files - Assists with eTMF oversight reviews to ensure quality, accuracy, and completeness - Interacts with CROs, vendors, investigators, monitors, and other external partners to provide information and resolution for specific study requests and issues - Responsible for document management within digital systems - Supports the development, maintenance, and implementation of SOPs and Working Instructions - Actively participates in the development of department initiatives; contributes ideas on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations - Identify gaps in operational processes to ensure compliance in applicable SOPs in the achievement of study milestones, data quality, and data integrity - Identify gaps in operational processes to ensure compliance in applicable SOPs in the achievement of study milestones, data quality, and data integrity Required Qualifications: - Bachelor's degree, or equivalent, in a biomedical, life science, or related field of study. Equivalent combination of education and applicable job experience may be considered - Familiar with FDA regulations, as well as GCP/ICH requirements - The ideal candidate will embody Travere's core values: Courage, Community Spirit, Patient Focus and Teamwork - Familiar with FDA regulations, GCPs and ICH guidelines is required - Proactive, self-starter who possesses strong multi-tasking and communication skills, both oral and written - Good problem-solving skills, and a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures - Intermediate proficiency in Microsoft Suite required Preferred Qualifications: - Minimum 1-2 years of related experience; clinical operations experience in a pharmaceutical or CRO setting preferred - Knowledge of Smartsheet, MS Project, Visio, and/or Veeva is a plus Required Skills: FDA regulations, Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, Clinical operations, Clinical study coordination, IRB submissions, Electronic Trial Master File (eTMF) management, Microsoft Office Suite, Smartsheet, MS Project, Visio, Veeva Benefits: Premium health, financial, work-life and well-being offerings for eligible employees and dependents, Wellness and employee support programs, Life insurance, Disability, Retirement plans with employer match, Generous paid time off, Combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock)