University of Southern California · 1 day ago
Lead Clinical Research Associate
San Diego, CA
Full-time
Hybrid
Mid, Senior Level
$128K/yr - $161K/yr
5+ years expThe University of Southern California's Keck School of Medicine - Alzheimer Therapeutic Research Institute is dedicated to advancing new treatments for Alzheimer’s Disease through innovative clinical trials. The Lead Clinical Research Associate will guide clinical monitors, ensure compliance with clinical research studies, and act as a liaison for communication among study teams.
EducationHigher EducationUniversities
Responsibilities
Incumbent will lead and provide guidance to clinical monitors for sponsor and investigator initiated clinical research studies
Assists in administration of the consent process, and ensures maintained records are accurate, complete, timely, and compliant
Serves as communications liaison for clinical monitoring and study teams, identifying, resolving, and escalating any issues, as appropriate
Develops and administers clinical trial education and training
Develop and maintain study specific clinical monitoring documentation
Review and contribute to clinical monitoring sections of other study documents
Support development and maintenance of departmental and study SOPs and Work Instructions
Conduct study specific onboarding and training of team members new to the study
Conduct onsite training visits
Represent Clinical Monitoring Team at study specific meetings
Provide study updates on Clinical Monitoring team metrics, site escalations, and other monitoring efforts
Support study start up, maintenance, and close out activities
Participate in interdepartmental meetings to accomplish study milestones
Collaborate with colleagues to address study issues
Expert knowledge and awareness of study manuals to serve as main point of contact for issues identified by study CRAs
Review study status reports and prioritize monitoring activities with study CRAs to meet study milestones
Review Monitor Visit Reports (MVR) and provide feedback to team
Provide oversight of monitor visit compliance with study plans
Escalate problematic behavior and poor performance to CRA Managers as needed
Participate in sponsor, internal, and regulatory audits as needed
Participate in eTMF filing efforts as needed
Review study data in accordance with Clinical Monitoring Plan
Issue and resolves queries in a timely manner
Review inclusion and exclusion criteria for study participants
Conduct monitor review of eCRFs
Ensure participant safety and protocol compliance
Conduct onsite and remote monitoring visits for assigned clinical sites
Review Investigator Site Files, study data, perform IP accountability, and other monitoring visit activities
Confirm sites are following GCP, regulatory requirements, study protocol, and ATRI policies
Act as main point of contact for assigned clinical sites and respond to communication via study inbox ticketing system in a timely manner
Experience in AD research is preferred
Qualification
Required
Bachelor's degree
5 years of experience
Extensive experience with monitoring of clinical trials and thorough knowledge of medical terminology
Demonstrated experience with the drug development process
Experience with ICH guidelines and Good Clinical Practices (GCP)
Proven ability to interpret and apply all relevant federal, state, and local laws, regulations, and policies regarding clinical trials and monitoring
Thorough knowledge of all applicable local and/or national regulations pertaining to clinical trials and monitoring
Preferred
Bachelor's degree
6 years of experience
Demonstrated leadership skills
Comprehensive understanding of all aspects of clinical trials
Experience maintaining currency with changing laws, regulations and policies
Experience in AD research is preferred
Company
University of Southern California
University of Southern California is a private research university offering opportunities for interdisciplinary study and collaboration.
10001+ employees
H1B Sponsorship
University of Southern California has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (253)
2024 (239)
2023 (172)
2022 (207)
2021 (182)
2020 (195)
Funding
Current Stage
Late StageTotal Funding
$19.64MKey Investors
Patient-Centered Outcomes Research InstituteCalifornia Institute for Regenerative MedicineCDA Foundation
2025-02-04Grant· $10.8M
2025-01-30Grant· $5.93M
2024-07-30Grant
Leadership Team
David A Barnhart
Director, USC Space Engineering Research Center
H
Hossein Pourmand
Assistant Vice President, Research Initiatives, University Advancement
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