Cardiovascular Associates of America - CVAUSA logo
Cardiovascular Associates of America - CVAUSA

Empowering Cardiovascular Specialists to Transform Patient Care

Clinical Research Regulatory Coordinator

Clinical ResearchClinical ResearchContractRemoteMid LevelTeam 51-200Since 2021H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

0

Seniority

Mid Level

Associate Degree2 yrs expEnglishGoogle Cloud Platform

Job Description

Clinical Research Regulatory Coordinator

Cardiovascular Associates of America - CVAUSA

• Provide centralized regulatory support for the CVRS clinical research network • Support regulatory start-up, site activation, IRB management, regulatory maintenance, and quality review activities across multiple clinical research sites • Prepare and maintain regulatory documentation • Coordinate IRB submissions and amendments • Manage electronic regulatory files within REALTIME • Support study activation activities • Conduct regulatory quality reviews • Serve as a regulatory resource for research sites • Ensure compliance with sponsor requirements, IRB requirements, Good Clinical Practice (GCP), FDA regulations, and CVRS Standard Operating Procedures

Job Requirements

  • Associate's Degree required
  • Bachelor's Degree in Life Sciences, Healthcare Administration, Public Health, or related field preferred
  • Minimum 2 years of clinical research regulatory experience required
  • Experience preparing IRB submissions, amendments, and continuing reviews required
  • Experience supporting study start-up and site activation activities preferred
  • Experience working in a multi-study or multi-site environment preferred
  • Experience using REALTIME CTMS and eRegulatory modules strongly preferred
  • Experience with central IRBs and local IRBs
  • Experience supporting sponsor and CRO interactions
  • Experience preparing studies for sponsor monitoring visits, audits, and inspections
  • Experience supporting remote research operations
  • Strong knowledge of ICH-GCP guidelines
  • Working knowledge of FDA regulations and human subject protection requirements
  • Exceptional attention to detail and document accuracy
  • Strong organizational and project management skills
  • Ability to manage multiple studies and competing deadlines
  • Excellent written and verbal communication skills
  • Ability to work independently in a remote environment
  • Proficiency with Microsoft Office applications and electronic regulatory systems.

Benefits

  • None specified

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