Job Duties
Study Management: Serve as the primary or co-coordinator for assigned Phase II/III clinical research studies, overseeing day-to-day operations from site initiation to closeout.
Protocol Compliance: Execute study procedures with strict adherence to Good Clinical Practice (GCP) guidelines, FDA regulations, and specific study protocols.
Patient Coordination: Guide participants through complex visit schedules, including consenting, screening, and coordinating cross-functional appointments (e.g., imaging, infusions).
Data Integrity: Timely and accurately enter, organize, and maintain study data across various electronic platforms (eSource, EDC, CTMS), proactively resolving queries.
Clinical Assessments: Conduct vital signs, ECGs, and other protocol-specific diagnostic, efficacy, and safety assessments.
Quality & Audit Readiness: Maintain impeccable regulatory and source documentation, ensuring the site is consistently prepared for sponsor monitoring visits and audits.
Job Requirements
Experience: 2 to 4+ years of hands-on experience coordinating industry-sponsored clinical trials (prior experience in CNS, Neurology, or Psychiatry is a strong plus).
Technical Skills: Demonstrated ability to navigate complex clinical trial management systems (CRIO eSource & CTMS) and EDC platforms quickly and accurately.
Organization & Precision: Exceptional attention to detail, capable of managing competing priorities and complex visit windows without compromising quality.
Communication: A strong, professional command of spoken and written English, with a proven ability to build rapport with older adult populations and their study partners.
Skills Required
- Two (2) or more years of clinical research coordinator experience
- Attention to detail and ability to handle multiple tasks with precision
- Demonstrated ability to work accurately and quickly with CTMS
- Command of professional spoken and written English
- Knowledge of GCP and ability to perform study procedures in accordance with study protocols
- Proven experience as primary coordinator on high-enrolling and/or highly complex drug trials
What We Do
Irvine Clinical Research is the largest independent clinical research site network on the US West Coast. Founded in 1978, the company specializes in conducting clinical trials for neurology, psychiatry, and obesity medicine. They provide clinical research opportunities and solutions to participants and sponsors, offering study-related medical care and medications at no cost to qualified participants, with a strong focus on Alzheimer’s Disease research.






