Clinical Trial Associate

🔥 19 hours ago

🇺🇸 United States – Remote

💵 $79k - $103k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

Where this job comes from

Posted on Generate Biomedicines's careers page, not through a job board

First seen by Remote Rocketship 19 hours ago

Still open on Generate Biomedicines's site. Checked 1 hour ago.

Logo of Generate Biomedicines

Generate Biomedicines

201 - 500 employees

Founded 2020

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

💰 $370M Series B on 2021-11

Biotechnology • Artificial Intelligence • Pharmaceuticals

Generate Biomedicines is a pioneering therapeutics company that stands at the intersection of machine learning, biological engineering, and medicine. They are leading the development of generative biology, a groundbreaking approach that uses artificial intelligence to create novel medicines with specific therapeutic functions. By studying millions of proteins, Generate Biomedicines has discovered generalizable rules by which nature encodes function, enabling them to generate medicines on demand across multiple therapeutic modalities. Their innovative platform promises to fundamentally change the way medicines are made, expanding technical possibilities and improving speed and success rates in drug discovery.

📋 Description

• Support execution of Phase 3 clinical trials, including global site activation, study conduct, and closeout activities • Manage Trial Master File (TMF) setup, maintenance, and quality control for real-time, inspection-ready documentation • Collaborate with CROs to review monitoring visit reports, protocol deviations, and key performance indicators • Coordinate with internal teams and vendors to align trial activities with Phase 3 regulatory requirements • Assist with collecting and reviewing essential regulatory documentation for trial initiation and maintenance • Organize study meetings and manage action and decision logs • Track timelines, escalate risks or delays, and contribute to mitigation planning • Support clinical audit readiness, including document review, reconciliation, and regulatory filing preparation • Maintain informed consent and protocol amendment tracking across global trial sites • Assist with clinical vendor invoice reconciliation and budget tracking • Work cross-functionally with Clinical Supply, Data Management, Regulatory, QA, and CROs to maintain inspection-readiness and GCP compliance

🎯 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) • Knowledge of FDA and ICH-GCP requirements for pivotal studies • Strong organizational skills, problem solving, and effective communication • Understanding of the clinical drug development process, including study design, protocol objectives and operational impacts • Understanding of site management and monitoring practices, data quality/integrity, and protocol deviation identification and reporting • Proficient in MS Office applications, including Word, Excel, and PowerPoint • Basic understanding of current ICH-GCP regulations/guidelines • Enthusiastic, proactive, collaborative, and dependable • Organized with attention to detail and able to problem solve • Comfortable in a fast-paced environment and able to manage and prioritize competing tasks • Willingness to travel as needed, up to 10–20% for monitoring-related work

🏖️ Benefits

• Annual bonus • Equity compensation • Competitive benefits package • Equal employment opportunity

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