We are seeking a Clinical Trial Associate (CTA) / Senior CTA to join our team at SpyGlass Pharma. The CTA is responsible for executing the tasks on the clinical team throughout the clinical trial.
Requirements
- Support the Clinical Affairs team to execute tasks throughout the clinical trials.
- Manage and execute the tasks for the strategic objectives defined by the project team
- Work with clinical team to execute global clinical strategies, programs, and protocols.
- Provide clinical support to interdisciplinary project teams, aligning with FDA/Regulatory Agency requirements, FDA/ICH guidelines, IRB/IEC requirements, Good Clinical Practices (GCP), and industry best practices.
- Be aware of clinical issues and help to resolve them.
- Participate in FDA, Regulatory Agency, IRB/IEC meetings as needed.
- Review of regulatory submissions, including clinical trial applications, IND, IDE, NDA, PMA, annual reports, CIB updates, meeting packages, technical files/design dossier for FDA and other regulatory agencies as needed.
- Facilitate regulatory document collection and follow-up with team members, ensuring that all documents and tasks are in accordance with predetermined timelines.
- Work in a dynamic, matrixed environment by collaborating closely with cross-functional teams, including R&D, Regulatory Affairs, Quality Assurance, and project management teams, while following GCP and industry best practices.
- Interact and coordinate with R&D staff (CMC and Engineering), vendors, and consultants to ensure compliance to applicable Design Control and pharmaceutical requirements (for drug/device combination products).
- Learn about clinical trends, changes, and requirements in the pharmaceutical industry, providing recommendations to senior management on regulatory matters.
Benefits
- Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options.
- Generous paid time off, including holidays, vacation days, and personal leave.
- Annual Bonus opportunity.
