We are seeking a Clinical Trial Associate to assist the project team in running the day-to-day operational activities of clinical studies. The ideal candidate will have a Bachelor’s degree in a biomedical, life science, or related field, and 1-2 years of related experience in clinical operations. Familiarity with FDA regulations, GCP/ICH requirements, and Travere’s Standard Operating Procedures is required.
Requirements
- 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.
- 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.
Benefits
- premium health insurance
- 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
