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.