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.
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.
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Irvine Clinical Research is a clinical research organization that conducts studies for pharmaceutical and biotechnology companies.