Clinical Trial Associate

Spyglass Pharma • Aliso Viejo, CA

1d • $90,000 - $110,000 • Onsite

About The Position

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 for supporting the Sr. Director, Clinical Affairs 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.

Requirements

• Bachelor’s degree in life sciences, healthcare, biomedical engineering, or a related field preferred.
• 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.

Responsibilities

• 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

• We are offering a range of $90,000 - $110,000, based on experience and qualifications, along with an Annual Bonus opportunity.
• Share in our success with stock options, giving you a stake in the company’s future.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level