Regulatory Associate
K2 Medical Research
Summary
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.
Job description
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).
Requirements
- Must have site-level regulatory exposure in clinical trials
- Experience in Study Start-Up processes is strongly preferred
- 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
- Ability to work collaboratively across departments to ensure seamless operational flow
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Supplemental Insurance
- 401(k) With Immediate Employer Match
- Paid Time Off
- Paid Holidays
- Four-Day Work Week
Company overview
K2 Medical Research is a privately-owned clinical research organization (CRO) headquartered in Orlando, Florida, with multiple research facilities across Florida, Tennessee, and Rhode Island. Founded in 2021, the company specializes in conducting multiphasic clinical trials that advance the development of innovative medical treatments while ensuring participant safety and privacy. K2 operates under the mission "Tomorrow's treatment today," focusing on connecting patients with cutting-edge therapies while contributing to medical progress. The company conducts research across diverse therapeutic areas including Alzheimer's disease, Parkinson's disease, depression, anxiety, NASH/fatty liver disease, migraines, diabetes, vaccines, and cardiovascular conditions. With a network of clinical research sites and a team of experienced physicians and researchers, K2 Medical Research emphasizes the concept of Clinical Research as a Care Option (CRAACO), positioning clinical trials as viable alternatives or supplements to conventional healthcare. The company has completed over 5,000 clinical trials and maintains a strong community outreach program focused on health equity and inclusive research practices.