Quick overview
Job description
Job Duties
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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.
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Protocol Compliance: Execute study procedures with strict adherence to Good Clinical Practice (GCP) guidelines, FDA regulations, and specific study protocols.
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Patient Coordination: Guide participants through complex visit schedules, including consenting, screening, and coordinating cross-functional appointments (e.g., imaging, infusions).
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Data Integrity: Timely and accurately enter, organize, and maintain study data across various electronic platforms (eSource, EDC, CTMS), proactively resolving queries.
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Clinical Assessments: Conduct vital signs, ECGs, and other protocol-specific diagnostic, efficacy, and safety assessments.
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Quality & Audit Readiness: Maintain impeccable regulatory and source documentation, ensuring the site is consistently prepared for sponsor monitoring visits and audits.
Job Requirements
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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).
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Technical Skills: Demonstrated ability to navigate complex clinical trial management systems (CRIO eSource & CTMS) and EDC platforms quickly and accurately.
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Organization & Precision: Exceptional attention to detail, capable of managing competing priorities and complex visit windows without compromising quality.
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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. Bilingual Mandarin a plus.
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