Clinical Research Associate

🕒 April 13

🇺🇸 United States – Remote

💵 $80k - $125k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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Alto Neuroscience

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Alto Neuroscience is a company that develops biology-driven medicines for neuropsychiatric conditions, aiming to enhance patient outcomes with a precision approach. By leveraging deep neurobiological insights, Alto creates clinical-stage drug candidates targeting core brain processes for conditions such as major depressive disorder, bipolar depression, and schizophrenia. The company focuses on innovating treatment methodologies to move beyond the traditional trial-and-error strategies in psychiatry.

📋 Description

• Perform site management and act as the primary liaison to the investigator and site staff • Conduct Site Evaluation, Site Initiation, Interim Monitoring, Close-out, and other study-specific visits • Assist with the preparation of appropriate training materials • Evaluate the quality and integrity of site practices to ensure GCP compliance • Manage site and study progress by tracking regulatory submissions and data query resolution • Ensure the collection and maintenance of required essential documents • Train site staff on proper preparation and handling of investigational products • Develop a patient recruitment plan in conjunction with the site • Verify informed consent and proper reporting of adverse events • Ensure deviations from regulations are documented and communicated appropriately • Assist with the coordination of investigator and study meetings

🎯 Requirements

• Experience monitoring clinical trials with rater-administered measures preferred • Certified Clinical Research Associate (CCRA) credentialing is preferred • Knowledge of the clinical research discipline, GCP, and ICH-E6 is essential • Proficiency with systems (CTMS, EDC, eTMF) and MS Office (Word, Excel, Outlook) • BS in scientific discipline or pharmacy, RN, or BSN degree, or equivalent combination of education and experience • Minimum 2 years of experience in relevant CRO/biotech/pharmaceutical industry, including on-site or remote monitoring experience

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development opportunities