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Senior Clinical Research Associate

Alto Neuroscience

Alto Neuroscience

Mountain View, CA, USA · United States
Posted on Thursday, July 4, 2024

The Sr. 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 Sr. CRA assists the Clinical Trial Manager and/or Clinical Project Manager by managing their assigned clinical sites to ensure timely review of data, identification of site issues, and prompt resolution of issues. The Sr. 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. Sr. CRAs may mentor or manage team members commensurate with experience.

DUTIES AND RESPONSIBILITIES

Specific responsibilities include, but are not limited to:

  • Perform site management and act as the primary liaison to the investigator and site staff ensuring regular communication
  • 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 provides 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 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 others in a mutually supportive and cooperative manner assisting others when possible to achieve study and project goals

LOCATION

TX, GA or FL

QUALIFICATIONS

Required Skills/Abilities:

  • Experience monitoring clinical trials with rater-administered measures preferred
  • 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
  • Good interpersonal skills are a requirement
  • Proficiency in MS Office (Word, Excel, Outlook)
  • The CRA must possess the ability to work closely with all disciplines within a small company, displaying innovative thinking, a strong sense of responsibility and accountability, and integrity

Education and Experience:

  • BS in scientific discipline or pharmacy, RN, or BSN degree, or equivalent combination of education and experience
  • 5 or more years of relevant CRO/biotech/pharmaceutical industry, including on-site or remote monitoring experience

Physical Requirements:

  • Capable of working in a fast-paced environment and taking initiative in seeking and utilizing available resources to effectively problem-solve, all while ensuring the clinical trial is executed within compliance of regulations and of the highest quality

Alto Neuroscience, Inc. 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.