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Medix™ · 4 days ago

Regulatory Analyst II - 249720

San Diego, CA

Full-time

Onsite

Mid Level

$36/hr - $52/hr

Medix™ is focused on regulatory lifecycle management of oncology clinical trials, seeking a Regulatory Analyst II to serve as the primary liaison between various stakeholders. The role involves managing regulatory submissions, ensuring compliance with regulations, and maintaining accurate documentation throughout the clinical trial process.

CrowdsourcingRecruitingSocial NetworkStaffing AgencyVenture Capital

Hiring Manager

Madeleine Munroe

Responsibilities

Independently manages the preparation and submission of research plans, protocols, and regulatory documents to the IRB

Drafts and edits Informed Consent Documents (ICDs), translating complex medical procedures and risks into layperson-friendly language

Oversees protocol amendments, annual renewals, and the reporting of unexpected problems or protocol deviations

Serves as a subject matter expert for Adverse Event (AE) and Serious Adverse Event (SAE) reporting to ensure human subject protection

Maintains "gold standard" regulatory binders (electronic and paper) and develops audit checklists to mitigate institutional risk

Manages Investigator CVs, FDA 1572 forms, and clinical lab certifications

Ensures all administrative records adhere to university and federal retention and destruction policies

Works with senior staff to prepare and file Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications or exemptions

Manages the registration and data entry of clinical trials into the ClinicalTrials.gov database to meet federal requirements

Synthesizes Investigator Brochures to create Investigational Drug Fact Sheets for clinical staff

Coordinates with ancillary committees (Biosafety, Stem Cell, Data Safety Monitoring) to align submission timelines with committee meeting dates

Maintains large-scale tracking databases and Clinical Trial Management Systems (CTMS) to provide real-time status reports on the research portfolio

Identifies bottlenecks in the submission pipeline and proposes solutions to enhance workflow

Qualification

FDA policiesGCPNIH guidelinesClinical Trial Management SystemsProtocol designIRB administrationProfessional CertificationBilingual skillsData managementQuery resolutionHigh-level English fluency

Required

Bachelor's degree in a science/social science field or equivalent experience

Proven track record in a clinical research environment (Academic, CRO, or Research Hospital)

Deep experience with FDA policies, GCP, and NIH guidelines

Strong knowledge of protocol design, data management, and query resolution

Familiarity with IRB administration, Bloodborne Pathogens, and IATA shipping standards

Proficiency in MS Office and Clinical Trial Management Systems (CTMS) like Velos

High-level English fluency (written/verbal) with the ability to translate medical jargon

Preferred

Oncology specific research experience

Professional Certification (SoCRA, ACRP, or RAPS)

Experience with Investigator-initiated or National Group trials

Bilingual skills (Spanish, Korean, Vietnamese, or Chinese)

Company

Medix™

Glassdoor3.3

Medix provides workforce solutions to clients and creates opportunity for contract employees.

Founded in 2001

Chicago, Illinois, USA

501-1000 employees

http://www.medixteam.com/

Funding

Current Stage

Late Stage

Total Funding

unknown

2022-09-16Acquired

Leadership Team

Andrew Limouris

Founder, President and CEO

Brian Anstiss

Chief Financial Officer

Recent News

Business Wire

Medix Staffing Solutions, Along With Its Medix Technology Division, Joins the Workday Partner Program to Deliver HCM and Financial Services to Healthcare Customers

2025-10-21

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