Clinical Trial Associate

Summary

Join Generate:Biomedicines, a leading therapeutics company, as a Clinical Trial Associate to support Phase 3 clinical trials. You will contribute to high-quality execution of pivotal trials, ensuring regulatory compliance and product approval. Collaborate with cross-functional teams, including CROs, to manage trial activities, documentation, and regulatory submissions. This role requires strong organizational skills, problem-solving abilities, and experience in clinical trial support. The ideal candidate will have a Bachelor’s degree, 2+ years of experience in Phase 3 clinical trials, and proficiency in clinical systems. This is an exciting opportunity to contribute to the final stages of clinical development within a fast-paced environment.

Requirements

• 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
• 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 need, however minimal (no more than 10-20% for monitoring related work)

Responsibilities

• 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

Preferred Qualifications

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