Regulatory Associate

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

At K2 Medical Research, we are transforming healthcare by delivering tomorrow’s treatments today. As a rapidly growing clinical research organization across Florida, Tennessee, and Rhode Island, we lead multiphasic trials in therapeutic areas ranging from neurodegenerative to cardiometabolic medicine. Our culture is grounded in clinical excellence and a patient-first mission. We are seeking mission-driven individuals ready to play a meaningful role in bringing life-changing treatments to the patients who need them most.

K2 is seeking an organized, detail-oriented Regulatory Associate to manage site-level regulatory operations, protocol activations, and study start-up compliance out of our clinic in The Villages, FL.

This is a non-patient-facing, highly process-driven role ideal for structured, methodical professionals who thrive in task organization, tracker management, and compliance oversight.

Primary 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).
• Delegation of Authority (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.

Knowledge, Skills, And Abilities

• Strong technical proficiency in eReg systems, clinical trial software, and advanced study-tracking tools (Excel/eTMF).
• In-depth, operational understanding of IRB submission processes, regulatory workflows, and DOA log maintenance.
• Exceptional organization, multi-tasking, and timeline-management capabilities in a high-volume environment.
• Strong follow-up skills with high accountability and attention to detail.
• Support the organization's goals, missions, and values.
• Ability to work collaboratively across departments to ensure seamless operational flow.

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 to apply (salary alignable with site-level structures).

Your growth and well-being are our priority. Our comprehensive benefits package for full-time employees includes medical, dental, and vision options, supplemental insurance plans, 401(k) with immediate employer match, generous paid time off, and paid holidays. Most notably, we support a healthy work-life balance through a four-day work week, consisting of 10-hour shifts from Monday through Thursday. Fridays are reserved only for critical business needs or administrative tasks; otherwise, they are your chance to kick-start your weekend.

Join the K2 Family: Where Compassion and Connection Lead the Way! At K2 Medical Research, people come first and we're seeking warm, wonderful humans who effortlessly click with everyone, from our incredible patients to brilliant physicians and dedicated research staff.

We are an equal opportunity employer. We celebrate what makes you uniquely you and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age, disability, genetic information, marital, or veteran statuses.

We value the differences among our team members and are committed to providing reasonable accommodations for qualified individuals with disabilities. If you require a reasonable accommodation to participate in the job application or interview process, please contact [e-mail]. We are here to ensure you have the support and tools you need to shine.