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CLINICAL RESEARCH ASSOCIATE

Galaxy Infotech INC

Hybrid in Cypress, California • Today

Easy Apply

Contract

60+

Senior Clinical Research Associate

EmployVision

Remote • Today

Easy Apply

Contract

$70 - $80

Sr. Project Manager - Clinical Research

Software Guidance & Assistance

Los Angeles, California • Today

Contract

USD 50.00 - 65.00 per hour

Quality Control Research Associate - III

Maxonic, Inc.

Walnut Park, California • 13d ago

Easy Apply

Contract

Depends on Experience

Clinical Data Associate

HR Solutions

Remote • 23d ago

Full-time

70000 - 85000

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 4 hours ago

Fitment

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Ayush Raj

Recruiter @ Galaxy Infotech INC

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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.

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.

Dice Id: 91138837
Position Id: 9135218
Posted 4 hours ago

Fitment