Jobs in Aliso Viejo, CA

About the role

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. This position has the responsibility of supporting the clinical department   in executing and implementing global clinical decisions. This includes responsibility for the clinical team’s creation of relevant documents and outputs including feasibility questionnaires, regulatory documents, enrollment reports, data listings, and patient summaries. The CTA will review the investigator brochures, study protocol synopsis, clinical study protocols, top line study data, Clinical Study Report (CSR), clinical sections of regulatory documents and the Annual reports. This position executes, implements, and manages various tasks to assist in the achievement of all activities related to the Clinical development program, including achievement of key program milestones within the planned timelines and budget. The position may interact with multiple levels in the organization, participating in discussions with management and providing clinical updates.

What you'll bring

• 2 years for CTA, 4 years for Sr CTA, 6 years for Sr CTA2, or 8 years for Principal CTA of experience in clinical affairs within the pharmaceutical or medical device industry, with a preference on drug and drug/device combination products. (A commensurate combination of education and experience will be considered.)
• Some experience in a cross-functional development team/subteam in a clinical development organization
• Knowledge of GCP and industry best practices with clinical trial management, monitoring, regulatory compliance, data management and statistical reporting.
• Knowledge of US clinical and regulatory requirements and guidelines for drug and drug/device combination products, including FDA/Regulatory Agency requirements, FDA/ICH guidelines, and IRB/IEC requirements.
• Awareness of preparing US IND/amendments, annual reports, and briefing books.
• Awareness of preparing the annual budget forecast and monitor expenditures.
• Knowledge of the CFR, FDA/ICH guidelines, GxP and cGMP as they pertain to pharmaceutical development and manufacturing.
• Previous experience conducting clinical studies, meetings, enrollment, and interactions with regulatory agencies.
• Willingness to learn leadership, communication, and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
• Awareness of clinical strategy development, investigational product supply, regulatory compliance, and clinical activities for clinical trials of all phases.
• Ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously while maintaining attention to detail and quality.
• Bachelor’s degree in life sciences, healthcare, biomedical engineering, or a related field preferred.

Benefits