Clinical Research Regulatory Affairs Contractor

Clinical Research Regulatory Affairs Contractor Emvera Health Scottsdale, AZ Job Details Contract 1 day ago Qualifications Document control within pharmaceutical industry ICH guidelines Regulatory submission editing and review Communication with regulatory authorities for clinical trials Ethical review application preparation Full Job Description

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