Vanguard Clinical, Inc.

Functional Service Provider specializing in clinical trial operations throughout the life cycle of drug development.

Senior Clinical Research Associate – Pool

Research AnalystResearch AnalystFull TimeRemoteTeam 51-200Since 2012H1B No SponsorCompany SiteLinkedIn

Location

Arizona + 13 moreAll locations: Arizona, California, Colorado, Florida, Kansas, North Carolina, Ohio, Oklahoma, Maryland, Massachusetts, Michigan, Tennessee, Texas, Washington

Posted

1 day ago

Salary

$125K - $150K / year

Bachelor Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

• Reporting to the Director, Clinical Monitoring, primarily responsible for the management of clinical sites and monitoring of clinical data at assigned sites • The Senior Clinical Research Associate (Sr. CRA) will independently execute monitoring responsibilities for clinical trials in Phases 1, 2, and 3, in accordance with ICH/GCP guidelines and Standard Operating Procedures (SOPs) • Prepares for and conducts site qualification, site initiation, interim, and closeout monitoring visits • Main point of contact between assigned sites and Sponsor • Conducts all monitoring with a strong focus on data integrity and patient safety, adhering to GCP protocol and sponsor requirements • Delivers high quality and timely reports following each monitoring visit • Completes and submits monitoring-related expense reports in accordance with the company and/or Client’s travel & expense guidelines • Works with the Clinical Operations Manager to identify, escalate, and resolve issues at assigned clinical sites • Maintains Trial Master File (TMF)/Electronic Trial Master File (eTMF) for assigned sites • Manages query resolution process with clinical sites and data management groups • Travel of up to 75% may be required, including globally • Quarterly travel to San Diego headquarters required, if not residing locally.

Job Requirements

  • 5+ years of independent clinical monitoring experience preferred
  • Self-motivation, flexibility, ability to establish and manage multiple priorities, and multi-task effectively
  • Must exercise sound judgment and take initiative
  • Ability to work independently with minimal supervision while producing accurate high quality and timely work
  • Must be able to work effectively within a team environment (independently and collaboratively)
  • Excellent written and verbal communication skills including strong professional presentation skills
  • Thorough knowledge and understanding of ICH/GCPs and applicable regulatory requirements
  • Solid computer skills, including working knowledge of Microsoft Office applications (Word, Excel Outlook, etc.)
  • Understanding of current GCPs/ICH/FDA regulations and guidelines to assess compliance with applicable regulations and guidelines
  • Bachelor of Science degree in a scientific discipline from an accredited college or university is strongly preferred.

Benefits

  • health insurance
  • 401k retirement plan
  • paid days off

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