Lead Clinical Research Associate

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 Alzheimers Disease (AD) through innovative clinical trials.

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. Duties will include but are not limited to:

• 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. Up to 50% travel may be required.
• 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.

Location: San Diego CA

The annual base salary range for this position is $128039.82- $161336.75. When extending an offer of employment the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position the candidates work experience education/training key skills internal peer equity federal state and local laws contractual stipulations grant funding as well as external market and organizational considerations.

USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying.

USC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other characteristic protected by law or USC policy. USC observes affirmative action obligations consistent with state and federal law. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance and with due consideration for patient and student safety. Please refer to theBackground Screening Policy Appendix Dfor specific employment screen implications for the position for which you are applying.

We provide reasonable accommodations to applicants and employees with disabilities. Applicants with questions about access or requiring a reasonable accommodation for any part of the application or hiring process should contact USC Human Resources by phone at or by email at. Inquiries will be treated as confidential to the extent permitted by law.

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