Note: The job is a remote job and is open to candidates in USA. Alto Neuroscience is focused on advancing precision psychiatry and improving treatment for mental health disorders. The Clinical Research Associate will oversee investigative sites, manage clinical trials, and ensure compliance with regulatory requirements while acting as the main liaison between investigators and the sponsor.
Responsibilities
- 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
Skills
- Experience monitoring clinical trials with rater-administered measures
- Must have experience with CNS
- 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
- Certified Clinical Research Associate (CCRA) credentialing is preferred
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