Clinical Research Associate

🔥 55 minutes ago

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Alto Neuroscience

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Alto Neuroscience is a clinical-stage biotechnology company developing biology-driven, precision medicines for neuropsychiatric conditions. The company uses measurements of brain biology and deep neurobiological research (built on about 15 years of field research) to predict clinical response and identify patients most likely to benefit from its drug candidates. Alto’s initial therapeutic focus includes major depressive disorder, bipolar depression, and schizophrenia; it emphasizes disrupting the traditional trial-and-error approach to psychiatry by leveraging CNS drug development and commercialization expertise. The company is based in Mountain View, California.

📋 Description

• Perform site management and act as the primary liaison to the investigator and site staff ensuring consistent and effective communication related to enrollment status, issues and other relevant study information • Conduct Site Evaluation, Site Initiation, Interim Monitoring, Close-out, and other study-specific visits including the completion of visit reports and follow-up letters after each visit • Assist with the preparation of appropriate training materials and provide protocol and study related training including GCP and regulatory requirements to assigned sites • Evaluate the quality and integrity of site practices to ensure GCP compliance and escalate any quality issues as appropriate • Manage site and study progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution • Ensure the collection and maintenance of required essential documents and ensure these documents are filed in the Investigator Site File and Trial Master File • Train site staff on proper preparation, handling, storage, and return/destruction of investigational product(s) and verify compliance during monitoring visits • Develop a patient recruitment plan in conjunction with the site, address challenges and barriers to enrollment, and report the subject recruitment rate to the Clinical Project Manager • Verify that written informed consent is obtained before each subject’s participation in the trial • Verify that source documents, other trial records, and CRFs are accurate, complete, and legible and that CRF entries reflect the source • Determine whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the Ethic Committees (IRB/IEC), Sponsor and the applicable regulatory requirement(s) • Ensure deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements are documented and communicated appropriately and take appropriate action to prevent recurrence of the detected deviations • Assist with the coordination and conduct of investigator and study meetings, including preparation and presentation of information • Collaborate with team members in a mutually supportive and cooperative manner, as required to achieve study and project goals

🎯 Requirements

• Experience monitoring clinical trials with rater-administered measures • Must have experience with CNS • Certified Clinical Research Associate (CCRA) credentialing is preferred • Proactive in identifying areas of improvement to drive efficiency within Clinical Operations • Knowledge of the clinical research discipline, GCP, and ICH-E6 is essential • Excellent interpersonal skills required • Proficiency with systems (CTMS, EDC, eTMF) and MS Office (Word, Excel, Outlook) • The CRA must possess the ability to work closely with cross-functional colleagues within a small company, displaying innovative thinking, analytical thinking, a strong sense of responsibility, accountability, and integrity • BS in scientific discipline or pharmacy, RN, or BSN degree, or equivalent combination of education and experience • Minimum 2 years of experience, relevant CRO/biotech/pharmaceutical industry, including on-site or remote monitoring experience

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible working hours • Paid time off