Clinical Trial Associate

Generate:Biomedicines is seeking a detail-oriented and highly collaborative Clinical Trial Associate to support clinical trials within our Clinical Development team. Reporting into Clinical Operations, this role will play a critical part in enabling high-quality execution of pivotal trials designed to support regulatory submissions and eventual product approval. The CTA will work cross-functionally with Clinical Supply, Data Management, Regulatory, QA, and CROs to maintain inspection-readiness, ensure compliance with GCP standards, and support key trial deliverables.

This is an exciting opportunity for someone who thrives in high-accountability environments and is eager to contribute to the final stages of clinical development with rigor and excellence.

· Support execution of Phase 1-3 clinical trials, including global site activation, study conduct, and closeout activities. · Manage Trial Master File (TMF) setup, maintenance, and QC to ensure real-time, inspection- ready documentation. · Collaborate with CROs to review monitoring visit reports, protocol deviations, and key performance indicators (KPIs). · Coordinate with internal teams and vendors to ensure trial activities align with the stringent regulatory requirements of Phase 1-3 trials.

Assist in the collection and review of essential regulatory documentation required for trial initiation and maintenance. · Organize study meetings, manage action and decision logs, and ensure high-quality documentation of operational progress. · Track progress against timelines, escalate risks or delays, and contribute to mitigation planning. · Support clinical audit readiness efforts, including document review, reconciliation, and regulatory filing preparation. · Maintain informed consent and protocol amendment tracking across global trial sites. · Assist in clinical vendor invoice reconciliation and budget tracking.

· Bachelor’s degree; life sciences or related degree preferred · 6 months to 1 year of experience supporting Phase 1-3 clinical trials at a sponsor or CRO. · Proficient in clinical systems (eTMF, CTMS) and knowledgeable of FDA and ICH-GCP requirements for pivotal studies. · Demonstrates strong organizational skills, problem solving, and effective communication · Demonstrates understanding of the clinical drug development process, including study design, protocol objectives and operational impacts · Ideal candidates will have understanding site management and monitoring practices, including importance of data quality/integrity, as well as fundamental understanding of protocol deviation identification and reporting · Must be proficient in MS Office applications (word, excel, and PowerPoint at a minimum) to support study/program documentation and deliverables · Basic understanding and importance of current ICH-GCP regulations/guidelines is required · Enthusiastic, proactive, collaborative, and dependable · Excited to learn and grow within the clinical operations team! · Organized (with attention to detail) and able to problem solve · Comfortable in a fast-paced environment and able to manage and prioritize competing tasks

A preferred candidate has been identified for this role but all applicants will be considered.

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By