Regulatory Associate

At K2 Medical Research we are transforming healthcare by delivering tomorrows 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 organizations 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 were 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 We are here to ensure you have the support and tools you need to shine.