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Emvera Health

3 jobs near Columbus, OH

Emvera Health

Patient Recruitment Specialist

Scottsdale, AZ · On-site

$18.25 - $23.25/hr

Salary: About This Role At Evera Health, we believe the most powerful force in clinical research is connecting the right patient to the right trial at the right time. As a Patient Recruitment ...

Clinical Research Regulatory Affairs Contractor

Emvera Health

Scottsdale, AZ • On-site

Contractor

Posted 22 days ago

Job description

Salary:

ABOUT THE ROLE

Emvera Health is a site network running concurrent industry-sponsored trials across cardiology, vascular, and metabolic indications. We need a regulatory contractor who can step into active obligations both ongoing study maintenance and incoming study startups and own them independently from day one. This is a site-side role; CRO or sponsor-only backgrounds will not translate.

RESPONSIBILITIES

Study Startup

  • Lead regulatory startup from site selection through SIV: IRB submissions, 1572s, FDFs, ICF tracked-changes review, and sponsor approvals
  • Execute sIRB reliance agreements and manage sponsor platform registrations (Veeva SiteID, EntraID, myLesson) within required timelines
  • Track sponsor-defined startup milestones; flag and resolve risks proactively
  • Build the ISF from day one; ensure all essential documents are in place prior to first subject enrollment

Ongoing Maintenance

  • Maintain ISFs across all active studies audit-ready at all times
  • Manage IRB continuing reviews, amendments, deviations, and safety reports across multiple concurrent protocols
  • Keep DoA logs, staff credentials, GCP certificates, and medical licenses current
  • Draft Notes to File, deviation documentation, and sponsor/IRB correspondence as needed

REQUIRED QUALIFICATIONS

  • 3+ years of site-side regulatory experience (research site, SMO, or site network required)
  • Direct experience leading study startup regulatory submissions at the site level
  • Hands-on IRB submission experience (Advarra, WCG, or equivalent)
  • Solid command of 1572s, DoA logs, ICF workflows, and ICH E6 R2/R3 GCP standards
  • Ability to manage multiple active protocols simultaneously without supervision
  • Current GCP certification

PREFERRED QUALIFICATIONS

  • Cardiology, vascular, or metabolic indication experience (PAD, hypertriglyceridemia, Lp(a), influenza vaccine)
  • Familiarity with Advarra CIRBI, SIP, Florence
  • CCRP or CCRC credential

WHAT TO EXPECT

  • Active portfolio with open regulatory items and incoming startups real responsibilities from week one
  • Lean, fast-moving team; direct access to site leadership and PIs
  • Room to grow as the network expands