Alto Neuroscience, Inc.
  • Los Altos, CA, USA
  • Full Time

The Clinical Research Associate (CRA) is responsible for assigned investigative site management in accordance with all applicable protocols, project plans, Sponsor SOPs, GCP guidelines and regulatory requirements. The CRA, with minimal direction and supervision assists the Clinical Project Manager in the planning, implementation, management, evaluation and analysis of clinical studies to meet overall project and departmental objectives. The CRA also functions as the primary liaison between the clinical investigators and Sponsor ensuring the quality, accuracy and integrity of data.

Essential Duties and Responsibilities

Responsibilities include but are not limited to:

  • Perform site management and act as the main line of communication to the investigator and site staff ensuring regular communications
  • Conduct Site Evaluation, Site Initiation, Interim Monitoring, Site Close-out, and other study-specific visits including the completion of trip reports and follow-up letters after each visit
  • Assists with the preparation of appropriate training materials and provides protocol and study related training including GCP and regulatory requirements training 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 delivered to the Trial Master File
  • Train site pharmacists on proper preparation, handling, storage, and return/destruction of investigational product(s) and verify compliance during monitoring visits
  • Verify that written informed consent is obtained before each subject's participation in the trial
  • Develop a patient recruitment plan in conjunction with the site and report the subject recruitment rate to the Clinical Project Manager
  • 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)
  • Communicate deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and take appropriate action designed to prevent recurrence of the detected deviations
  • Assists with the coordination and conduct of investigator and study meetings, including preparation and presentation of information
  • Collaborates and interacts with others in a mutually supportive and cooperative manner assisting others when possible to achieve study and project goals

Education and Experience

  • At least 3 years of relevant CRO/biotech/pharmaceutical industry on-site monitoring experience
  • BS in scientific discipline or pharmacy, RN, or BSN degree, or equivalent combination of education and experience
  • Experience monitoring clinical trials with Rater administered measures
  • Thorough knowledge of ICH GCP and FDA guidelines
  • Certified Clinical Research Associate (CCRA) credentialing is preferred
  • Ability to travel up to 75%
  • Strong organizational, IT and administration skills with attention to detail
  • Excellent written and interpersonal communication skills and the ability to build effective relationships both internally and with trial center staff
Alto Neuroscience, Inc.
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