Clinical Research Associate

Alto Neuroscience

164d•$80,000 - $125,000•Remote

About The Position

The Clinical Research Associate (CRA) oversees assigned investigative sites in accordance with applicable protocols, project plans, Sponsor SOPs, GCP guidelines, and regulatory requirements from site initiation through site close out. The CRA supports the Clinical Trial Manager and/or Clinical Project Manager by managing assigned sites to support enrollment, timely data review, identification of site issues, and prompt issue resolution. The CRA serves as the primary liaison between the clinical investigator and the Sponsor, ensuring recruitment, enrollment, and site activities are completed on time, within budget, and to high data-quality standards. The position is remote and requires 60% travel, described as 1–2 days per week. The listed base salary range is $80,000–$125,000, depending on qualifications and experience.

Requirements

Experience monitoring clinical trials with rater-administered measures.
Experience with CNS.
Knowledge of clinical research, GCP, and ICH-E6.
Excellent interpersonal skills.
Proficiency with CTMS, EDC, eTMF, and Microsoft Office applications, including Word, Excel, and Outlook.
Ability to work closely with cross-functional colleagues in a small company, with innovative and analytical thinking, responsibility, accountability, and integrity.
Bachelor of Science in a scientific discipline or pharmacy, RN, BSN, or an equivalent combination of education and experience.
At least 2 years of relevant CRO, biotech, or pharmaceutical industry experience, including on-site or remote monitoring experience.

Nice To Haves

Certified Clinical Research Associate (CCRA) credentialing is preferred.
Proactive identification of areas for improvement to drive efficiency within Clinical Operations.

Responsibilities

Manage assigned sites and serve as the primary liaison to investigators and site staff, communicating about enrollment status, issues, and relevant study information.
Conduct site evaluation, site initiation, interim monitoring, close-out, and other study-specific visits; complete visit reports and follow-up letters after each visit.
Help prepare training materials and deliver protocol- and study-related training, including GCP and regulatory requirements, to assigned sites.
Evaluate site practices for quality, integrity, and GCP compliance, and escalate quality issues as appropriate.
Track regulatory submissions, recruitment, case report form (CRF) completion, data queries, and other site and study progress.
Ensure required essential documents are collected, maintained, and filed in the Investigator Site File and Trial Master File.
Train site staff in the preparation, handling, storage, and return or destruction of investigational products, and verify compliance during monitoring visits.
Develop patient recruitment plans with sites, address enrollment challenges and barriers, and report subject recruitment rates to the Clinical Project Manager.
Verify that written informed consent is obtained before each subject participates in the trial.
Verify that source documents, trial records, and CRFs are accurate, complete, and legible, and that CRF entries reflect source documents.
Determine whether adverse events are reported within required time periods under GCP, the protocol, ethics committee requirements, Sponsor requirements, and applicable regulations.
Ensure protocol, SOP, GCP, and regulatory deviations are documented and communicated appropriately, and take action to prevent recurrence.
Assist with coordinating and conducting investigator and study meetings, including preparing and presenting information.
Collaborate supportively and cooperatively with team members to achieve study and project goals.