The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of an expert panel of scientific collaborators committed to advancing the development of new treatments for Alzheimer’s Disease (AD) through innovative clinical trials.
Roles and Responsibilities
Incumbent will provide oversight to the progress of clinical trials at study sites, and ensure that they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). Duties will include but are not limited to:
- Conduct onsite and remote monitoring for assigned clinical sites and co-monitor visits. Review Investigator Site Files, study data, perform IP reconciliation, review Informed Consent Forms, and other monitoring visit activities.
- Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies. Work with sites to document deviations from standard procedures.
- Review study data, issue and resolves queries. Review inclusion and exclusion criteria for study participants. Conduct monitor review of eCRFs. Ensure participant safety and protocol compliance.
- Act as main point of contact for assigned clinical sites.
- Thorough understanding of study protocol and manuals.
- Work closely with Lead Clinical Monitor/Lead CRA to escalate site compliance issues.
- Participate in monitoring activities to achieve study milestones.
- Utilize internal and study specific software and tools.
- Assist in training new monitors on study specific or onsite procedures as needed.
- Participate in sponsor, internal, and regulatory audits as needed.
- Participate in eTMF filing efforts as needed.
- Experience in AD research is preferred.
- Up to 50% travel may be required.
- Bachelor's degree, Combined experience/education as substitute for minimum education.
- 2 years Minimum Field of Expertise: Monitoring of clinical trials and medical terminology. Knowledge of the drug development process.
- Thorough knowledge of ICH guidelines and Good Clinical Practices (GCP). Understanding of FDA regulations pertaining to Good Clinical Practices.
- Thorough knowledge of local and/or country’s regulation pertaining to clinical trials and monitoring.