About Alto Neuroscience, Inc.At Alto Neuroscience, you will play a pivotal role in advancing precision psychiatry and improving how mental health disorders are treated. Join us in building the next generation of personalized neuroscience-based therapeutics.Primary RoleThe Clinical Research Associate (CRA) is responsible for the oversight of assigned investigative sites in accordance with all applicable protocols, project plans, Sponsor SOPs, GCP guidelines, and regulatory requirements from site initiation through site close out. The CRA assists the Clinical Trial Manager and/or Clinical Project Manager by managing their assigned clinical sites to ensure enrollment, timely review of data, identification of site issues, and prompt resolution of issues. The CRA is the primary liaison between the clinical investigator and the Sponsor to ensure the recruitment, enrollment, and site activities are executed on time, within budget, and with the highest quality data standards.What you'll doPerform 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 informationConduct 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 visitAssist with the preparation of appropriate training materials and provide protocol and study related training including GCP and regulatory requirements to assigned sitesEvaluate the quality and integrity of site practices to ensure GCP compliance and escalate any quality issues as appropriateManage site and study progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolutionEnsure the collection and maintenance of required essential documents and ensure these documents are filed in the Investigator Site File and Trial Master FileTrain site staff on proper preparation, handling, storage, and return/destruction of investigational product(s) and verify compliance during monitoring visitsDevelop 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 ManagerVerify that written informed consent is obtained before each subject’s participation in the trialVerify that source documents, other trial records, and CRFs are accurate, complete, and legible and that CRF entries reflect the sourceDetermine 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 deviationsAssist with the coordination and conduct of investigator and study meetings, including preparation and presentation of informationCollaborate with team members in a mutually supportive and cooperative manner, as required to achieve study and project goalsLocationRemoteSalary Range$80-125K Base Salary*depending on qualifications and experience levelTravel Required60% travel required(1-2 days per week)QualificationsRequired Skills:Experience monitoring clinical trials with rater-administered measuresMust have experience with CNSCertified Clinical Research Associate (CCRA) credentialing is preferredProactive in identifying areas of improvement to drive efficiency within Clinical OperationsKnowledge of the clinical research discipline, GCP, and ICH-E6 is essentialExcellent interpersonal skills requiredProficiency 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 integrityEducation and Experience:BS in scientific discipline or pharmacy, RN, or BSN degree, or equivalent combination of education and experienceMinimum 2 years of experience, relevant CRO/biotech/pharmaceutical industry, including on-site or remote monitoring experienceAlto Neuroscience is an equal-opportunity employer that does not discriminate on the basis of sex, age, race, color, religion, marital status, sexual orientation, gender identity, pregnancy, disability, or any other characteristic protected by law. We offer a welcoming and inclusive environment in service to one another, our products, the diverse consumers we represent, and the communities we call home. We do all of this with kindness, empathy and respect for each other. The above is intended to describe the general content of and requirements for the performance of this job. It should not be construed as an exhaustive statement of duties, responsibilities or physical requirements.