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
