Senior Clinical Research Associate - CRA

Responsibilities

• Coordinate with study teams to support the successful initiation and execution of clinical trials
• Identify, evaluate, and qualify investigators and research sites within the Los Angeles region and surrounding areas
• Prepare and review essential documentation required for site initiation and regulatory readiness
• Conduct on-site monitoring visits and remote monitoring activities while maintaining detailed documentation of findings and follow-up actions
• Collaborate with Clinical Trial Managers and Project Managers to escalate site concerns and resolve operational challenges
• Review study data on an ongoing basis to identify discrepancies, missing information, or protocol deviations
• Support the full monitoring lifecycle, including pre-study visits, site initiation visits, routine monitoring visits, and close-out visits
• Verify that informed consent procedures and protocol requirements are properly followed to protect research participants
• Track and follow up on adverse events and serious adverse events while ensuring appropriate reporting procedures are followed
• Ensure the accuracy and integrity of case report form data through a comprehensive source document review
• Maintain compliance with study monitoring plans, standard operating procedures, and regulatory guidelines
• Participate in investigator meetings, project team meetings, and study-related teleconferences
• Maintain ongoing training related to ICH GCP, study protocols, and internal procedures
• Support regulatory documentation tracking, site performance evaluation, and study timeline adherence

Qualifications

• Five or more years of clinical research monitoring experience as a Clinical Research Associate
• At least three years of experience supporting studies in central nervous system indications, such as neurology or psychiatry-related therapeutic areas
• Minimum four years of experience working in contract-based CRA positions, such as independent contractor, consultant, or similar arrangements
• Experience conducting site monitoring visits and managing investigator site relationships
• Bachelor’s degree from a four-year university, preferably in a scientific or health-related field
• Candidates with significant clinical research experience, nursing background, or relevant medical certifications may be considered in place of a traditional degree
• Able to work as an independent vendor through an established corporation or LLC with appropriate business insurance
• Must have authorization to work in the United States
• Must be located within the greater Los Angeles area
• Availability to support studies for at least one year
• Strong communication skills in English and the ability to navigate complex clinical research discussions using medical terminology
• Professional communication skills with the ability to collaborate effectively across study teams and research sites
• Clinical research certifications, such as CCRA, CCRP, or similar credentials, are beneficial but not required