Regulatory Operations Lead - Clinical Trials (4-Day Week)

ADP, Inc.; Ocala (FL); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with immediate employer match

Generous paid time off

Paid holidays

Four-day work week (Mon-Thu, 10-hour)

Job summary

K2 Medical Research in The Villages, FL is seeking a Regulatory Associate to manage site-level regulatory operations, IRB submissions, DOA logs, and study start-up activities in a fast-paced, process-driven environment.

This full-time role focuses on compliance with GCP and FDA regulations, coordinating with sponsors and monitors, and driving timelines from packet receipt to site activation while maintaining meticulous regulatory records.

Qualifications

• Strong technical proficiency in eReg systems and study-tracking tools (Excel/eTMF).
• In-depth understanding of IRB submission processes, regulatory workflows, and DOA log maintenance.
• Exceptional organization and timeline-management in a high-volume environment.

Responsibilities

• Prepare, submit, and track IRB submissions, amendments, continuing reviews, safety reports, and ICFs.
• Maintain and audit DOA logs and regulatory binders to ensure compliance.
• Drive study start-up workflows from packet receipt through SIV and study activation.
• Maintain electronic regulatory documents in compliance with GCP and FDA regulations; act as regulatory contact for monitors and auditors.
• Manage high-volume, concurrent trials and coordinate follow-ups with sponsors and IRBs.

Skills

eReg systems

IRB submissions

DOA logs

Study start-up

Regulatory compliance

Tools

Excel

eTMF

eReg software

Job description

K2 Medical Research in The Villages, FL is seeking a Regulatory Associate to manage site-level regulatory operations, IRB submissions, DOA logs, and study start-up activities in a fast-paced, process-driven environment.

This full-time role focuses on compliance with GCP and FDA regulations, coordinating with sponsors and monitors, and driving timelines from packet receipt to site activation while maintaining meticulous regulatory records.