Lead Clinical Research Associate – (San Diego, California, United States)

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.

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 $110,750.64- $158,554.68. 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 candidate’s 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.

Minimum Education:
Bachelor’s degree

Additional Education Requirements
Combined experience/education as substitute for minimum education

Minimum Experience:
5 years

Minimum Skills:
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 Education:
Bachelor’s degree

Preferred Experience:
6 years

Preferred Skills:
Demonstrated leadership skills. Comprehensive understanding of all aspects of clinical trials.
Experience maintaining currency with changing laws, regulations and policies.

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