Clinical Research Regulatory Affairs Contractor

Job Description

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