Regulatory Associate

Summary: The Regulatory Associate supports clinical research trials by ensuring the timely and accurate preparation and submission of regulatory and IRB documentation for new and ongoing studies. On average, this position provides primary regulatory support for approximately 45 clinical trials across multiple sites. The Regulatory Associate works closely with Investigators, Clinical Operations, Sponsors, CROs, IRBs, and other stakeholders to ensure the research site follows applicable regulations, GCP, ICH guidelines, HIPAA, sponsor requirements, and company SOPs for the conduct of clinical pharmaceutical and device protocols.

The Regulatory Associate serves as a key point of coordination for regulatory compliance throughout the study lifecycle and is responsible for preparing and maintaining regulatory documents, tracking submissions, approvals, and expiring documentation, facilitating communication with internal and external stakeholders, and identifying outstanding items that may impact study timelines or compliance.

This position works under limited supervision, applies ethical principles and multiple regulations to complex research projects, and always maintains the confidentiality of subject, sponsor, and study-related information.

Duties and Responsibilities

Regulatory Submissions and IRB Management Review study protocols, informed consent documents, responses to stipulations, and other study-related documentation to ensure conformance with all applicable requirements. Prepare, populate, and coordinate the initial submission of regulatory documents to the IRB, sponsors, and state or federal regulatory offices as necessary.

Compile study information and prepare and submit initial, continuing, and final reports to the IRB and/or sponsor. Prepare applicable submission forms and submit updated documents, including amendments, addendums, investigator brochures, safety information, Form FDA 1572s, and informed consent documents. Track submissions, approvals, stipulations, and outstanding items; coordinate responses to sponsor, CRO, and IRB requests.

Manage and update employee CVs and ensure copies of all current and applicable medical licenses and training documentation are on file. Create error-free written documents and reports, such as cover letters, notes-to-file, and memos. Regulatory Documentation and Compliance Prepare, maintain, and provide oversight of all research-related regulatory documents, in accordance with applicable regulations, GCP, ICH guidelines, sponsor requirements, and company SOPs.

Accurately file and maintain all necessary logs and documents within regulatory binders and electronic regulatory systems, including filing, reconciliation, and quality control. Create study source documents using sponsor-provided information and EDC/CRF, and maintain document and version control on all released source documents.

Prepare for and assist with monitoring visits, audits, and inspections. Manage and assist with the archival of clinical trial documents and records. Identify, escalate, and resolve missing, expired, or inconsistent regulatory documentation in coordination with appropriate personnel. Maintain compliance with HIPAA regulations and the confidentiality of subject information and sponsor trade secrets.

Study Support and Communication Attend site initiation visits and support study activation activities as needed. Interact with sponsors, CROs, IRBs, investigators, and research staff, as well as physicians, nurses, administrative staff, and central laboratory/imaging personnel. Coordinate multiple projects with competing priorities and deadlines based on protocol directives and study volume.

Exercise judgment within the limits defined by clinical trial protocols and standard operating procedures, and under the direction of the study Investigator and supervisor. Perform other duties as assigned.

Qualifications

Required Bachelors degree in a scientific, health-related, or relevant field or 3-4 years of equivalent clinical research experience or a combination of the two. Working knowledge of FDA regulations, 21 CFR, ICH/GCP, HIPAA, and IRB requirements. Experience with clinical trial and/or regulatory documentation. Proficiency with Microsoft Office, particularly Word and Excel, and with web-based enterprise solutions and electronic case report form (EDC/CRF) systems.

Strong organizational, written, and verbal communication skills with exceptional attention to detail. Ability to manage multiple studies, priorities, and time-sensitive deadlines, and to adapt to changing priorities. Ability to collaborate effectively with investigators, research staff, sponsors, CROs, IRBs, and internal departments in a diplomatic and professional manner.

Ability to read and interpret documents such as delegation log templates, protocols, procedure manuals. Ability to write routine reports and correspondence, and draft NTF documents. Completion of required GCP training. Strongly Preferred 1-2 years of clinical research regulatory experience. Experience with IRB submissions and correspondence.

Experience working directly with sponsors and CROs. Experience with Clinical Research IO (CRIO) or similar electronic regulatory platforms. Experience supporting pharmaceutical and/or medical device research Experience supporting liver disease related and or neurological related trials Knowledge of FDA Form 1572, investigator qualifications, and essential document requirements.

Familiarity with medical terminology. Work Environment and Physical Demands: The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Occasional domestic and/or international travel may be required. Ability to work in an upright and/or stationary position for 6-10 hours per day. Frequent mobility required; occasional squatting, kneeling, or bending. Light to moderate lifting and carrying of objects, with a maximum lift of 20-50 lbs.