Job Description
The academic research institute, located in San Diego, California, is comprised of scientific collaborators dedicated to advancing the development of new treatments for Alzheimer's disease through innovative clinical trials.
The Clinical Research Associate – Clinical Monitor will oversee clinical trial activities at assigned study sites, ensuring studies are conducted, documented, and reported in compliance with study protocols, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
Key Responsibilities
- Conduct onsite and remote monitoring visits, including co-monitoring activities at assigned clinical study sites.
- Review Investigator Site Files, study data, Informed Consent Forms, and other essential clinical trial documentation.
- Perform Investigational Product (IP) reconciliation and other required monitoring activities.
- Ensure clinical study sites comply with GCP, regulatory requirements, study protocols, and ATRI policies.
- Identify, document, and follow up on protocol deviations and compliance concerns.
- Review clinical study data, issue and resolve queries, and verify inclusion and exclusion criteria for study participants.
- Conduct monitoring reviews of electronic Case Report Forms (eCRFs) to ensure data accuracy, participant safety, and protocol compliance.
- Serve as the primary point of contact for assigned clinical study sites.
- Maintain a thorough understanding of study protocols, procedures, and manuals.
- Collaborate with the Lead Clinical Monitor/Lead CRA to escalate site compliance issues.
- Participate in monitoring activities to support study milestones and timelines.
- Utilize internal systems and study-specific software and tools.
- Assist with training new clinical monitors on study-specific procedures and onsite monitoring processes.
- Participate in sponsor, internal, and regulatory audits as needed.
- Support electronic Trial Master File (eTMF) documentation and filing activities.
Experience in Alzheimer's Disease research is preferred
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