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Fda Consulting Contract Research Jobs (NOW HIRING)

Sinai Chicago

RESEARCH IRB COORDINATOR

Chicago, IL · On-site

... contract research organizations (CROs), and medical device manufacturers, consulting with the IRB Chair or the RTO Manager where appropriate. • Supports FDA-regulated IND and IDE trials by ensuring ...

Sinai Chicago

RESEARCH IRB COORDINATOR

Chicago, IL

... contract research organizations (CROs), and medical device manufacturers, consulting with the IRB Chair or the RTO Manager where appropriate. · Supports FDA-regulated IND and IDE trials by ensuring ...

Frontage Laboratories

Research Technician

Chicago, IL · On-site

$24 - $28/hr

... Contract Research Organization operating over 25 state-of-the-art laboratories across the US ... FDA guidelines. Roles & Responsibilities : * Duties include handling, dosing, bleeding, weighing ...

New

Houston Methodist

At Houston Methodist, the Research Contract Analyst position is responsible for various duties ... consulting agreements, professional services agreements, and confidentiality agreements, for ...

Vcu Rrtc

$70 - $80/hr

... negotiate industry contracts, and secure patents and licensing agreements. Our commitment to ... FDA program Administrator/Clinical Research Monitor Responsibilities: * Perform risk-based ...

New

Socket.dev

Public Health Research Scientist

Mocksville, NC · On-site

$90 - $130/hr

... contract research organizations (CROs), academic collaborators, consultants, and external ... Experience supporting FDA regulatory submissions, including PMTA, SPMTA, IND, NDA, 510(k), De Novo ...

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Fda Consulting Contract Research information

What is the difference between Fda Consulting Contract Research vs Fda Regulatory Affairs Specialist?

AspectFda Consulting Contract ResearchFda Regulatory Affairs Specialist
CredentialsTypically requires scientific or clinical degrees, experience in research, and industry certificationsRequires degrees in life sciences, regulatory certifications, and knowledge of FDA regulations
Work EnvironmentContract research organizations, pharmaceutical or biotech companies, consulting firmsPharmaceutical companies, biotech firms, regulatory agencies
Employer & Industry UsageHired for specific research projects, clinical trial support, or consulting rolesEnsures compliance, prepares submissions, and manages regulatory strategies

Fda Consulting Contract Research focuses on conducting research and supporting clinical trials, often on a project basis, while Fda Regulatory Affairs Specialists handle regulatory compliance, submissions, and strategy within organizations. Both roles require scientific knowledge and understanding of FDA processes but serve different functions within the drug development lifecycle.

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Fda Consulting Contract Research jobs near you
Infographic showing various Fda Consulting Contract Research job openings in the United States as of August 2026, with employment types broken down into 1% Internship, 1% As Needed, 84% Full Time, 11% Part Time, 1% Temporary, and 2% Contract. Highlights an 84% Physical, 4% Hybrid, and 12% Remote job distribution.

DEA Compliance & Audit Readiness Consultant

The FDA Group

Miami, FL • On-site

Full-time

Posted 15 days ago

Job description

DEA Compliance & Audit Readiness Consultant

Location: Onsite – North of Miami, Florida
Engagement Type: Consulting / Contract
Start: ASAP, with initial assessment targeted for early September
Duration: Through September, with potential ongoing support

Position Overview

We are seeking an experienced DEA Compliance & Audit Readiness Consultant to support a clinical research organization in South Florida. The consultant will conduct a comprehensive DEA Compliance Gap Assessment and Audit Readiness Review in preparation for an anticipated DEA inspection.

Following the initial assessment, the consultant may provide ongoing onsite support leading up to and potentially during the DEA inspection.

Key Responsibilities

  • Conduct an onsite DEA Compliance Gap Assessment/Audit Readiness Review.
  • Evaluate current controlled-substance practices and identify potential compliance gaps.
  • Assess organizational readiness for an upcoming DEA inspection.
  • Provide subject matter expertise related to Schedule I controlled substances used in clinical trials.
  • Provide guidance regarding Schedule II–V controlled substances.
  • Assess applicable compounding pharmacy requirements, particularly when an external compounding pharmacy supplies controlled substances or other drugs to the clinical trial site.
  • Provide practical recommendations and remediation guidance for identified compliance gaps.
  • Assist with inspection-readiness activities and preparation of site personnel.
  • Provide ongoing onsite compliance support, as needed, leading up to the DEA inspection.
  • Potentially provide onsite SME support during the DEA inspection.

Consultant Qualifications

  • Demonstrated experience with DEA compliance, audits, and/or DEA inspection readiness assessments.
  • Strong knowledge of federal controlled-substance requirements.
  • Experience or subject matter expertise involving Schedule I controlled substances, preferably within clinical research or clinical trial environments.
  • Knowledge of requirements applicable to Schedule II–V controlled substances.
  • Knowledge of regulatory requirements involving compounding pharmacies and controlled substances, including scenarios in which an external compounding pharmacy supplies drugs to a clinical trial site.
  • Experience conducting compliance gap assessments, mock inspections, audit readiness reviews, or similar regulatory assessments.
  • Ability to provide practical, hands-on remediation and inspection-readiness support.
  • Prior experience supporting or participating in DEA inspections is highly desirable.
  • Former FDA experience is a plus but is not required.

Location & Availability

This engagement requires onsite support north of Miami, Florida. Consultants located in the Fort Lauderdale/Miami/South Florida area are strongly preferred.

Candidates should be available to begin as soon as possible, with the initial DEA readiness assessment anticipated for early September and additional support potentially continuing through the end of September.