Senior Clinical Trial Associate

About Tr1X

Tr1X is a private, clinical-stage biotechnology company focused on developing a novel class of regulatory T cell-based products to cure autoimmune and inflammatory diseases. Founded by industry experts, including the scientists who discovered Type 1 regulatory T (Tr1) cells, the company is developing a pipeline of off-the-shelf allogeneic cell therapies for autoimmune diseases with high unmet medical need. Our TRX cells are designed to mimic the function of naturally occurring Tr1 cells, which work to restore immune tolerance, stopping severe autoimmune and inflammatory disease in its tracks. Tr1X is the first company ever to use an allogeneic engineered Tr1 cell therapy in clinical trials. Tr1X is headquartered in San Diego, CA. For more information, please visit www.tr1x.bio.

Position Summary

The Senior Clinical Trial Associate (Sr. CTA) supports clinical studies and the Clinical Operations department by managing various administrative tasks including generating agendas and minutes, maintaining study tracking, and conducting filing and quality reviews. The Sr. CTA participates in process improvement initiatives across the department. The Sr. CTA is instrumental in collaborating cross-functionally, working closely with study teams from vendors and CROs to achieve departmental and project goals. The Sr. CTA adheres to the Company’s core values and complies with all applicable regulations, ICH-GCP guidelines, and SOPs. The Sr. CTA understands trial and study site management, vendor management, and has experience participating in the full cycle of studies from start-up to close-out.

Key Responsibilities

• Provide general administrative support to the Clinical Operations department
• Assist in the production of presentations as needed for project, departmental, and/or business development
• Assist the Study Lead(s) with Sponsor oversight of CRO, including study-specific documentation review and QC, and reviews of ICFs, study plans, study reference manuals, eCRFs, etc.
• Assist with creation and maintenance of study metrics trackers, tools and reports
• Assist in coordination and tracking of clinical trial samples
• Ensure required study documents are submitted to the CRO-held eTMF
• Assist the Study CTM(s) with Sponsor oversight of CRO-held eTMFs, including periodic audit and findings resolution
• Assist the Study CTM(s) in executing clinical monitoring oversight
• Assist in review/QC for study documents as assigned
• Assist the CTM(s) and clinical team with Investigator meeting coordination, activities preparation and generate meeting minutes
• Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.) when needed
• Attend internal and external team meetings/teleconferences and generate meeting agenda and minutes when needed
• Travel to clinical sites as needed.
• Perform other responsibilities as may be required based on business needs.

Required Qualifications & Experience

• Bachelor's degree or an equivalent combination of education, training and/or experience.
• Minimum 3 years of related experience in pharmaceutical industry, clinical research organization (CRO), or related role;CRO experience preferred
• Experience working on Phase 1 and 2 studies; experience in global/international studies is a plus
• Experience and knowledge of ICH GCP, eTMF management and DIA TMF Reference Model
• Excellence in task management and collaboration
• Demonstrated passion to succeed through professionalism and integrity in all actions and relationships with employees and other colleagues while maintaining a fun and collegial demeanor

Other Requirements

• Legally authorized to work for any employer in the U.S.
• Must be willing to travel domestically to clinical sites as necessary (up to 15% time)
• Position is 100% on-site in San Diego

The job responsibilities and requirements provided above are intended to describe the general nature of the work performed by individuals assigned to this job classification. It is not intended to be an exhaustive list of all duties and requirements. Tr1X retains the right to add, change, or delete duties, education, experience or any other requirements of the position at any time.

Working at Tr1X

At Tr1X, our team is united by a singular shared mission: to transform patients’ lives through breakthrough science. We are a group of skilled experts driven by urgency, innovation and a collaborative spirit. Our culture thrives on excellence, positivity, persistence and the agility to tackle new challenges head-on. With an unwaver