Regulatory Start-Up Pro - Clinical Trials (4-Day Week)

K2 Medical Research; Ocala (FL); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Supplemental insurance plans

401(k) with employer match

Paid time off

Paid holidays

Four-day work week

Job summary

K2 Medical Research in The Villages, FL is seeking a Regulatory Associate to manage site-level regulatory operations, IRB submissions, and study-start activities in a highly process-driven environment. This non-patient-facing role emphasizes accuracy, tracker management, and compliance oversight across multiple trials.

The ideal candidate has site-level regulatory exposure in clinical trials and experience with study start-up, DOA logs, and eReg systems, enabling rigorous regulatory oversight

Qualifications

• Site-Level Regulatory Experience: Must have site-level regulatory exposure in clinical trials. Experience in Study Start-Up processes is strongly preferred.
• Diverse Backgrounds Encouraged: Candidates with strong Clinical Research Coordinator (CRC) or Project Manager (PM) backgrounds who possess significant regulatory exposure are encouraged to apply.
• Sponsor / CRO / CRA Backgrounds: Transferable candidates from Sponsor, CRO, or CRA roles seeking site-level operational roles are welcome (salary alignable with site-level structures).

Responsibilities

• IRB Oversight & Submissions: Prepare, submit, and track initial study submissions, protocol amendments, continuing reviews, safety reports, and informed consent forms (ICFs) to central and local Institutional Review Boards (IRBs).
• DOA Logs: Maintain and audit Delegation of Authority (DOA) logs, ensuring all site staff signatures, training records, and regulatory binder documents are accurate and fully compliant prior to study participation.
• Study Start-Up & Timeline Management: Drive study start-up workflows from initial packet receipt through site initiation visits (SIV) and study activation. Proactively manage trial trackers and study timelines to prevent bottlenecks.
• Regulatory Compliance & Audits: Maintain essential electronic regulatory documents (eReg) in compliance with Good Clinical Practice (GCP), FDA regulations, and Sponsor guidelines. Serve as the primary regulatory point of contact for Sponsor/CRO monitors and auditors.
• High-Volume Multitasking & Tracking: Manage high-volume, concurrent clinical trials across varying stages of study lifecycle. Drive rigorous follow-up with internal teams, Sponsors, and IRBs to ensure actionable items are closed efficiently.

Skills

eReg systems

Clinical trial software

Study-tracking tools

Excel

eTMF

Tools

Excel

eTMF

Job description

K2 Medical Research in The Villages, FL is seeking a Regulatory Associate to manage site-level regulatory operations, IRB submissions, and study-start activities in a highly process-driven environment. This non-patient-facing role emphasizes accuracy, tracker management, and compliance oversight across multiple trials.

The ideal candidate has site-level regulatory exposure in clinical trials and experience with study start-up, DOA logs, and eReg systems, enabling rigorous regulatory oversight