Regulatory Associate

K2 Staffing LLC•Maitland, FL

13h•Onsite

About The Position

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 Maitland, 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.

Requirements

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.
Site-level regulatory exposure in clinical trials.
Experience in Study Start-Up processes is strongly preferred.

Nice To Haves

Candidates with strong Clinical Research Coordinator (CRC) or Project Manager (PM) backgrounds who possess significant regulatory exposure are encouraged to apply.
Transferable candidates from Sponsor, CRO, or CRA roles seeking site-level operational roles are welcome to apply (salary alignable with site-level structures).

Responsibilities

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).
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.
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.
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.
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.