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CLINICAL RESEARCH ASSOCIATE

Galaxy Infotech INCCypress, CA🇺🇸United States

Quick overview

SeniorityMid Senior
Work modeHybrid
LocationCypress, CA, United States
Clinical ResearchComplianceCypressGoogle CloudPharmacySite Management

Job description

Clinical Research Associate
20-25/hrs per week( part-time)
Either location in Cypress, CA or Overland Park, KS.
As of now the client has said candidates must have Phase 1 healthy-volunteer monitoring experience.
Candidates must have direct Phase I healthy-volunteer monitoring experience, demonstrated external investigator-site monitoring and management experience, and the ability to independently manage senior-level CRA responsibilities without significant training or oversight.
Key Responsibilities
Clinical Monitoring & Site Management
  • Conduct assigned site qualification, initiation, interim, and close-out monitoring visits as applicable, following study protocols, Clinical Monitoring Plans, ICH-Google Cloud Platform, and relevant regulatory requirements.
  • Perform Source Data Review (SDR) and Source Data Verification (SDV), as applicable, to assess protocol compliance, participant safety, and data integrity.
  • Monitor Phase I healthy-volunteer studies, including dose observation visits, participant eligibility reviews, and other study-specific monitoring activities.
  • Review informed consent documentation, adverse event reporting, protocol deviations, and other relevant study records.
  • Review Investigator Site Files (ISFs), clinical sample management and processing documentation, pharmacy records, and applicable investigational product documentation.
  • Conduct unblinded monitoring visits when assigned, including applicable pharmacy-related and investigational product documentation review, while following study-specific blinding procedures.
  • Identify, document, escalate, and follow up on monitoring findings, deviations, and compliance concerns.
  • Prepare monitoring visit reports and related follow-up documentation according to study requirements.

Study Preparation & Coordination
  • Prepare Clinical Monitoring Plans using established templates, subject to manager review.
  • Prepare comprehensive Site Initiation Visit (SIV) presentations and supporting materials using established templates, including presentations of 100+ slides.
  • Independently plan, schedule, and coordinate assigned monitoring visits and activities.
  • Manage monitoring documentation, site communication, and follow-up activities according to study timelines.
  • Communicate with investigators, site personnel, sponsors, and internal study teams regarding monitoring activities and findings.

Internal Clinic & External Site Monitoring
  • Support monitoring at Altasciences' Phase I clinical research facilities and external investigator sites.
  • Understand the differences between internal clinic monitoring, which emphasizes SDR due to integrated eSource/EDC systems, and external-site monitoring, where source documentation and verification workflows differ.
  • Independently manage external investigator-site monitoring responsibilities, including site engagement, communication, coordination, and follow-up.
  • Travel to external sites as required by study assignments.
  • Participate in applicable departmental training and meetings to maintain consistency with Altasciences' clinical monitoring procedures.

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