Galaxy Infotech INC
Galaxy Infotech INC

CLINICAL RESEARCH ASSOCIATE

Hybrid in Cypress, CA, US • Posted 3 hours ago • Updated 3 hours ago
Contract Independent
Contract W2
12 Months
No Travel Required
Hybrid
60+
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Clinical Research

Summary

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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91138837
  • Position Id: 9135218
  • Posted 3 hours ago
Contact the job poster
AR

Ayush Raj

Recruiter @ Galaxy Infotech INC

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