Clinical Trial Associate

The Role

Generate:Biomedicines is seeking a detail-oriented and highly collaborative Clinical Trial Associate to support Phase 3 clinical trials within our Clinical Development team. 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.

Here's how you will contribute

• Support execution of Phase 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 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.

The Ideal Candidate will have

• Bachelor's degree; life sciences or related degree preferred
• 2+ years of experience supporting Phase 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
• Travel is required as needed, however minimal (no more than 10-20% for monitoring related work)